Trial Outcomes & Findings for Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide (NCT NCT02805725)

Last Updated: 2026-01-14

Results Overview

MTD was determined by testing increasing doses of trabectedin up to 0.60 mg/m2 via IV on dose escalation cohorts 1 to 4 with 3 to 6 participants each.The MTD is defined as the highest dose at which no more than 1 in 6 of the patients in the cohort experienced a DLT in the first treatment cycle. See subsequent primary outcome measure for the DLT definition.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

50 participants

Primary outcome timeframe

During the first cycle (28 days)

Results posted on

2026-01-14

Participant Flow

Phase I (dose escalation sudy): 20 patients ; Phase II (interim analysis) : 16 patients ; Phase II (overall study): 30 patients.

Participant milestones

Participant milestones
Measure	Cohort 1: Trabectedin 0.30 mg/m2 IV + CP Trabectedin 0.30 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 1 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Phase II: Trabectedin 0.50 mg/m2 IV + CP Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in the phase II part of the study. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 2: Trabectedin: All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial. Phase 2: Cyclophosphamide: All patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial.
Phase I (Dose escalation part) STARTED	3	3	7	7	0
Phase I (Dose escalation part) COMPLETED	3	3	5	5	0
Phase I (Dose escalation part) NOT COMPLETED	0	0	2	2	0
Phase II STARTED	0	0	0	0	30
Phase II Interim analysis (stage 2 of Simon's design)	0	0	0	0	16
Phase II COMPLETED	0	0	0	0	24
Phase II NOT COMPLETED	0	0	0	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Phase II: Trabectedin 0.50 mg/m2 IV + CP Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in the phase II part of the study. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 2: Trabectedin: All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial. Phase 2: Cyclophosphamide: All patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial.
Phase I (Dose escalation part) Clinical progression	1	0	0
Phase I (Dose escalation part) Adverse Event	1	2	0
Phase II Protocol Violation	0	0	6

Baseline Characteristics

Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Trabectedin 0.30 mg/m2 IV + CP n=3 Participants Trabectedin 0.30 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 1 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: Phase I trial based on a dose escalating study design (3+3 traditional design) assessing four dose levels of Trabectedin in combination with metronomic cyclophosphamide (CP). A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP n=3 Participants Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: Phase I trial based on a dose escalating study design (3+3 traditional design) assessing four dose levels of Trabectedin in combination with metronomic cyclophosphamide (CP). A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP n=7 Participants Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: Phase I trial based on a dose escalating study design (3+3 traditional design) assessing four dose levels of Trabectedin in combination with metronomic cyclophosphamide (CP). A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP n=7 Participants Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: Phase I trial based on a dose escalating study design (3+3 traditional design) assessing four dose levels of Trabectedin in combination with metronomic cyclophosphamide (CP). A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Phase II: Trabectedin 0.50 mg/m2 IV + CP n=30 Participants Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in the phase II part of the study. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 2: Trabectedin: Patients will be included in a single-arm phase II trial. Administrated dose will be the RP2D defined in the dose escalation part of the trial. The design will follow a two-stage Simon's optimal design. All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial. Phase 2: Cyclophosphamide: All patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial.	Total n=50 Participants Total of all reporting groups
Sex: Female, Male Male	1 Participants n=14 Participants	0 Participants n=10 Participants	5 Participants n=24 Participants	4 Participants n=78 Participants	17 Participants n=713 Participants	27 Participants n=82 Participants
Age, Continuous	61 years n=14 Participants	67 years n=10 Participants	61 years n=24 Participants	57 years n=78 Participants	67 years n=713 Participants	62.5 years n=82 Participants
Sex: Female, Male Female	2 Participants n=14 Participants	3 Participants n=10 Participants	2 Participants n=24 Participants	3 Participants n=78 Participants	13 Participants n=713 Participants	23 Participants n=82 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	0 Participants n=713 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Asian	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	0 Participants n=713 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	0 Participants n=713 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Black or African American	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	0 Participants n=713 Participants	0 Participants n=82 Participants
Race (NIH/OMB) White	3 Participants n=14 Participants	3 Participants n=10 Participants	7 Participants n=24 Participants	7 Participants n=78 Participants	30 Participants n=713 Participants	50 Participants n=82 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	0 Participants n=713 Participants	0 Participants n=82 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants	0 Participants n=78 Participants	0 Participants n=713 Participants	0 Participants n=82 Participants
Region of Enrollment France	3 participants n=14 Participants	3 participants n=10 Participants	7 participants n=24 Participants	7 participants n=78 Participants	30 participants n=713 Participants	50 participants n=82 Participants

PRIMARY outcome

Timeframe: During the first cycle (28 days)

Population: 4 patients were not evaluable for MTD/DLT assessment.

Outcome measures

Outcome measures
Measure	Phase I: Evaluable for Safety n=16 Participants All phase I patients received Trabectedin IV (3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks) in combination with CP (bi-daily (50 mg x 2) and given on a week on/week off ) according to the established dose escalation schedule. Patients who withdrew before completing the cycle 1 of treatment for other reason than DLT were not evaluable.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP.	0.50 mg/m^2	—	—	—

PRIMARY outcome

Timeframe: During the first cycle (28 days)

Population: 4 patients were not evaluable for DLT evaluation as they did not complete the DLT assessment period: 2 in cohort 3 and 2 in cohort 4

A DLT was defined as a treatment-related (at least possibly related) adverse event using the CTCAE V4.0, occuring during the fist cycle of treatment (28 days), that meets one of the following criteria: * Any grade-4 toxicity (except for vomiting without maximal symptomatic/prophylactic treatment) * Grade-3 non-haematological toxicity lasting \> 7days (except for 1rst episode of nausea without maximal symptomatic/ prophylactic treatment and if toxicity is transaminitis, which may last \> 7 days if total bilirubin is normal or grade-1) * Grade-3 hematologic toxicity lasting for \> 7days * Grade 4 neutropenia with fever * Grade \> 2 thrombocytopenia with bleeding * Is unrelated to disease, disease progression, inter-current illness, or concomitant medications.

Outcome measures

Outcome measures
Measure	Phase I: Evaluable for Safety n=3 Participants All phase I patients received Trabectedin IV (3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks) in combination with CP (bi-daily (50 mg x 2) and given on a week on/week off ) according to the established dose escalation schedule. Patients who withdrew before completing the cycle 1 of treatment for other reason than DLT were not evaluable.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP n=3 Participants Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP n=5 Participants Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP n=5 Participants Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
Phase I: Number of Patients Who Experienced Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Phase II : 6 months after the start of treatment

Population: Stage 1 of Simon's design (interim analysis): 16 patients were included at this stage and 13 were evaluable for the primary endpoint. Stage 2 Simon's design (Final analysis): 30 patients were included at this stage and 24 were evaluable for the primary endpoint.

Non-progression is defined as complete or partial response (CR, PR) or stable disease (SD), as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as a \>=30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at baseline (SSD); Stable disease (SD) is defined as Neither sufficient shrinkage (compared to baseline) to qualify for PR or CR nor sufficient increase (taking as reference the SSD or while on study, whichever is smallest) to qualify for progressive disease (PD).

Outcome measures

Outcome measures
Measure	Phase I: Evaluable for Safety n=24 Participants All phase I patients received Trabectedin IV (3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks) in combination with CP (bi-daily (50 mg x 2) and given on a week on/week off ) according to the established dose escalation schedule. Patients who withdrew before completing the cycle 1 of treatment for other reason than DLT were not evaluable.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
Phase II: Percentage of Patients in Non-progression at 6 Months (RECIST V1.1) Interim analysis (Stage 1 of Simon's design)	23.1 percentage of participants Interval 5.0 to 53.8	—	—	—
Phase II: Percentage of Patients in Non-progression at 6 Months (RECIST V1.1) Overall (stage 2 of Simon's design)	12.5 percentage of participants Interval 2.7 to 32.4	—	—	—

SECONDARY outcome

Timeframe: Throughout the treatment period, an average of 6 months

Population: 4 patients were not evaluable for DLT evaluation as they did not complete the DLT assessment period: 2 in cohort 3 and 2 in cohort 4

Objective response is defined as complete or partial response (CR, PR) as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR) is defined as disappearance of all target lesions; Partial Response (PR) is defined as a \>=30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at baseline (SSD).

Outcome measures

Outcome measures
Measure	Phase I: Evaluable for Safety n=3 Participants All phase I patients received Trabectedin IV (3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks) in combination with CP (bi-daily (50 mg x 2) and given on a week on/week off ) according to the established dose escalation schedule. Patients who withdrew before completing the cycle 1 of treatment for other reason than DLT were not evaluable.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP n=3 Participants Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP n=5 Participants Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP n=5 Participants Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
Phase I: Percentage of Patients With Objective Response (RECIST V1.1)	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From start of treatment, and during treatment until death for any cause for up to 12 months.

Population: Stage 1 of Simon's design (interim analysis): 16 patients were included at this stage and 13 were evaluable for efficacy endpoints. Stage 2 Simon's design (Final analysis): 30 patients were included at this stage and 24 were evaluable for efficacy endpoints. The upper limit for the 95%CI for OS was not reached due to insufficient number of participants with events, and thus entered as "NA" (Not available).

Overall survival is defined as the time from the study initiation to death (any cause). Median overall survival was reported using kaplan-Meier method for calculation.

Outcome measures

Outcome measures
Measure	Phase I: Evaluable for Safety n=24 Participants All phase I patients received Trabectedin IV (3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks) in combination with CP (bi-daily (50 mg x 2) and given on a week on/week off ) according to the established dose escalation schedule. Patients who withdrew before completing the cycle 1 of treatment for other reason than DLT were not evaluable.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
Phase II: Median Overall Survival	12.0 months Interval 5.8 to The upper limit for the 95%CI for OS was not reached due to insufficient number of participants with events, and thus entered as "NA" (Not available).	—	—	—

SECONDARY outcome

Timeframe: From start of treatment, and during treatment until progression or death for any cause for up to 12 months.

Progression-free survival is defined as the time from study treatment initiation to disease progression or death (of any cause), whichever occurs first. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. Median PFS was reported using kaplan-Meier method for calculation.

Outcome measures

Outcome measures
Measure	Phase I: Evaluable for Safety n=24 Participants All phase I patients received Trabectedin IV (3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks) in combination with CP (bi-daily (50 mg x 2) and given on a week on/week off ) according to the established dose escalation schedule. Patients who withdrew before completing the cycle 1 of treatment for other reason than DLT were not evaluable.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
Phase II: Median Profression-free Survival	1.9 months Interval 1.7 to 4.4	—	—	—

Adverse Events

Cohort 1: Trabectedin 0.30 mg/m2 IV + CP

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Cohort 2: Trabectedin 0.40 mg/m2 IV + CP

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Cohort 3: Trabectedin 0.50 mg/m2 IV + CP

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Cohort 4: Trabectedin 0.60 mg/m2 IV + CP

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Phase II: Trabectedin 0.50 mg/m2 IV + CP

Serious events: 20 serious events

Other events: 30 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Trabectedin 0.30 mg/m2 IV + CP n=3 participants at risk Trabectedin 0.30 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 1 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP n=3 participants at risk Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP n=5 participants at risk Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP n=5 participants at risk Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Phase II: Trabectedin 0.50 mg/m2 IV + CP n=30 participants at risk Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in the phase II part of the study. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 2: Trabectedin: All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial. Phase 2: Cyclophosphamide: All patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial.
Musculoskeletal and connective tissue disorders Chest pain	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 8 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Blood and lymphatic system disorders Febrile pancytopenia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Worsening of GGT increased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations GGT increased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	6.7% 2/30 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations CPK increased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	6.7% 2/30 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Acute pancreatitis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Small intestine obstruction	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders Disease progression	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders Oedema lower limb	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders General physical health deterioration	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Cardiac disorders Arrhythmia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Cardiac disorders Decompensation cardiac	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Cruralgia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Septic shock	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations CPK increase	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Platelet count decreased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukemia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor bleeding	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor progression	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Spinal cord compression	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Renal and urinary disorders Ureteric dilatation	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Vascular disorders Vein compression	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Surgical and medical procedures Exeresis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Vascular disorders Obstructive thrombosis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	3.3% 1/30 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.

Other adverse events

Other adverse events
Measure	Cohort 1: Trabectedin 0.30 mg/m2 IV + CP n=3 participants at risk Trabectedin 0.30 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 1 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 2: Trabectedin 0.40 mg/m2 IV + CP n=3 participants at risk Trabectedin 0.40 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 2 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 3: Trabectedin 0.50 mg/m2 IV + CP n=5 participants at risk Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 3 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Cohort 4: Trabectedin 0.60 mg/m2 IV + CP n=5 participants at risk Trabectedin 0.60 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in cohort 4 of dose escalation. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 1: Trabectedin: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design Phase 1: Cyclophosphamide: A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.	Phase II: Trabectedin 0.50 mg/m2 IV + CP n=30 participants at risk Trabectedin 0.50 mg/m2 will be administered intravenously (IV), 3-hour infusion weekly for three consecutive weeks (days 1, 8 and 15) every 4 weeks, in the phase II part of the study. Cyclophosphamide (CP) will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule. 1 cycle = 28 days Phase 2: Trabectedin: All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial. Phase 2: Cyclophosphamide: All patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial.
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	66.7% 2/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	80.0% 4/5 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	63.3% 19/30 • Number of events 21 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Eye disorders Diplopia	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Ear and labyrinth disorders Conjunctivitis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	80.0% 4/5 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	36.7% 11/30 • Number of events 13 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 6 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Bloating	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	6.7% 2/30 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Aphta	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Black stools	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Food disgust	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Gastrointestinal pain	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Hemorrhoids	66.7% 2/3 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Mucositis oral	66.7% 2/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	66.7% 2/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	26.7% 8/30 • Number of events 8 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	66.7% 2/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	80.0% 4/5 • Number of events 6 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	80.0% 4/5 • Number of events 8 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	66.7% 20/30 • Number of events 26 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Periodontal disease	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	80.0% 4/5 • Number of events 6 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	50.0% 15/30 • Number of events 17 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders Edema limbs	33.3% 1/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 6/30 • Number of events 6 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders Fatigue	100.0% 3/3 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	100.0% 3/3 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	100.0% 5/5 • Number of events 6 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	90.0% 27/30 • Number of events 32 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders Fever	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	80.0% 4/5 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders Pain	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders Non-cardiac Chest pain	66.7% 2/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders Injection site reaction	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
General disorders General disorders and administration site condition - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 6 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Laryngitis	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Mucosal infection	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Pharyngitis	66.7% 2/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Tooth infection	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Genital herpes	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Rhinitis infective	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	6.7% 2/30 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Sinusitis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Injury, poisoning and procedural complications Dermatitis radiation	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Injury, poisoning and procedural complications Fracture	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Injury, poisoning and procedural complications Right ankle sprain	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 12/30 • Number of events 14 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Alkaline phosphatase increased	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	23.3% 7/30 • Number of events 7 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 10/30 • Number of events 10 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations CPK increased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 6/30 • Number of events 9 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Creatinine increased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	6.7% 2/30 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations GGT increased	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	80.0% 4/5 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	26.7% 8/30 • Number of events 8 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Lymphocyte count decreased	66.7% 2/3 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	100.0% 5/5 • Number of events 5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	86.7% 26/30 • Number of events 26 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Neutrophil count decreased	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	36.7% 11/30 • Number of events 13 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	23.3% 7/30 • Number of events 11 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations White blood cell decreased	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations LDH increased	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Hyperleukocytosis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Intermittent monocytosis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Investigations Investigations - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	30.0% 9/30 • Number of events 9 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Musculoskeletal and connective tissue disorders Ante-brachial flexion restriction	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Dysesthesia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Dysgeusia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Neuralgia	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Paresthesia	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	6.7% 2/30 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Somnolence	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Psychiatric disorders Anxiety	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Renal and urinary disorders Chronic kidney disease	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Renal and urinary disorders Hematuria	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Renal and urinary disorders Renal insufficiency	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Reproductive system and breast disorders Metrorrhagia	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	40.0% 2/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	60.0% 3/5 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 2 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	16.7% 5/30 • Number of events 5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Vesicular murmur diminution	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	13.3% 4/30 • Number of events 4 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	10.0% 3/30 • Number of events 3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Skin and subcutaneous tissue disorders Telangiectasia	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Skin and subcutaneous tissue disorders Erythemato-vesicular eruption (zona type	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Vascular disorders Hypotension	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Vascular disorders Lymphedema	33.3% 1/3 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.
Vascular disorders Thromboembolic event	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/3 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	20.0% 1/5 • Number of events 1 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/5 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.	0.00% 0/30 • Adverse events must be reported for 30 days after the last treatment administration or until the start of a new antitumor therapy, whichever occurs first. Phase I: approximatively 6 months after the start of study treatment. Phase II: approximatively 6 months after the start of study treatment.

Additional Information

Pr Antoine Italiano

Institut Bergonie

Phone: + 33 5 47 30 60 88

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place