Trial Outcomes & Findings for Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML). (NCT NCT03298984)

Last Updated: 2023-11-15

Results Overview

Determine the safety and tolerability including the maximum tolerated dose (MTD) of alvocidib when administered over a range of doses on Days 1-3 followed by Ara-c/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

During the first cycle

Results posted on

2023-11-15

Participant Flow

32 patients at 3 sites; Recruitment started 25Sep2017 Recruitment ended 20Mar2020

4 dose escalation cohorts. If 1 of 3 subjects in a cohort experienced a DLT, up to 3 additional subjects were treated at that dose level. If no DLTs observed, the alvocidib dose was escalated in a new cohort of 3 subjects. At MTD level 20 additional subjects enrolled for confirmation of safety as well as additional safety analysis.

Participant milestones

Participant milestones
Measure	Alvocidib 20/30 mg/m2 Alvocidib 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
Overall Study STARTED	3	3	3	23
Overall Study COMPLETED	2	2	1	8
Overall Study NOT COMPLETED	1	1	2	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Alvocidib 20/30 mg/m2 Alvocidib 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
Overall Study Physician Decision	1	0	0	6
Overall Study Lack of Efficacy	0	1	1	4
Overall Study Relapsed disease (following remission)	0	0	1	1
Overall Study Adverse Event	0	0	0	1
Overall Study Death	0	0	0	2
Overall Study Insurance Company Decision	0	0	0	1

Baseline Characteristics

Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alvocidib 20/30 mg/m2 n=3 Participants Alvocidib 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 n=3 Participants Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 n=3 Participants Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 n=23 Participants Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	23 Participants n=4 Participants	32 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	14 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	20 Participants n=4 Participants	24 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: During the first cycle

Outcome measures

Outcome measures
Measure	All Participants n=32 Participants All participants who received at least 1 dose of Alvocidib, either at 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours, or 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
Maximum Tolerated Dose (MTD) of Alvocidib Bolus	30 mg/m2	—	—	—
Maximum Tolerated Dose (MTD) of Alvocidib IV infusion	60 mg/m2	—	—	—

PRIMARY outcome

Timeframe: During the first cycle

Determine the safety and tolerability including dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days 1-3 followed by Ara-c/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and previously untreated AML

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received at least 1 dose of Alvocidib, either at 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours, or 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 n=3 Participants Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 n=3 Participants Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 n=23 Participants Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) of Alvocidib	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Best response during duration of study

CR: Measurable residual disease is positive or unknown; BM blasts (bls) \<5%; no circulating bls and bls w/ Auer rods; no extramedullary disease; ANC \>1.0 x 109/L; platelets \>100 x 109/L. CRMRD-: CR w/ negativity genetic marker. CRi: CR except residual neutropenia or thrombocytopenia. MLFS: BM bls \<5%; no bls with Auer rods; no extramedullary disease; no hematologic recovery required. PR: all hematologic CR criteria; decrease (dec) BM bls % to 5-25%; dec pretreatment BM bls % by \>50%. SD: no CRMRD-/CR/CRi/PR/MLFS; PD criteria not met. PD: increase (inc) BM bls % and/or inc absolute bls in blood: 50% inc BM bls over baseline (\>15% point inc required in cases w/ \<30% bls at baseline or persistent BM bls % of \>70% over at least 3 months; without at least 100% improvement in ANC to absolute level \[\>0.5 x 109/L and/or platelet count to \>50 x 109/L non-transfused); or \>50% inc in peripheral bls to \>25 x 109/L (in the absence of differentiation syndrome); or new extramedullary disease.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received at least 1 dose of Alvocidib, either at 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours, or 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 n=3 Participants Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 n=3 Participants Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 n=23 Participants Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria Complete Remission MRD Positive or Unknown (CR)	1 participants	2 participants	0 participants	7 participants
Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria Complete Remission MRD Negative (CRMRD-)	2 participants	0 participants	2 participants	8 participants
Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria Partial Remission (PR)	0 participants	1 participants	0 participants	1 participants
Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria Stable Disease	0 participants	0 participants	0 participants	2 participants
Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria Progressive Disease (PD)	0 participants	0 participants	1 participants	4 participants
Antileukemic Activity of Alvocidib Plus 7+3 - Response to Treatment Based on 2017 ELN Response Criteria Not Evaluated	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: During Cycle 1 beginning at 1st dose of study drug through Day 50 + or - 3 days

The dose at which \< 1 of 6 patients experience a DLT during Cycle 1 with the next higher dose having at least 2 of 3 to 6 patients experiencing a DLT during Cycle 1

Outcome measures

Outcome measures
Measure	All Participants n=32 Participants All participants who received at least 1 dose of Alvocidib, either at 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours, or 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
Recommended Phase 2 Dose (RP2D) of Alvocidib in Combination With 7+3 Bolus	30 mg/m2	—	—	—
Recommended Phase 2 Dose (RP2D) of Alvocidib in Combination With 7+3 IV infusion	60 mg/m2	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: During duration of study

Percentage of participants with a CRMRD- response at the end of Cycle 1

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants who received at least 1 dose of Alvocidib, either at 20 mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours, 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours, or 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 n=3 Participants Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 n=3 Participants Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 n=23 Participants Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
Minimal Residual Disease (MRD) Using Standardized Techniques	66.7 percentage of participants	0 percentage of participants	66.7 percentage of participants	34.8 percentage of participants

Adverse Events

Alvocidib 20/30 mg/m2 (N=3)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Alvocidib 30/40 mg/m2 (N=3)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Alvocidib 30/50 mg/m2 (N=3)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Alvocidib 30/60 mg/m2 (N=23)

Serious events: 5 serious events

Other events: 23 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Alvocidib 20/30 mg/m2 (N=3) n=3 participants at risk Alvocidib 20mg/m2 bolus followed by 30 mg/m2 IV infusion over 4 hours	Alvocidib 30/40 mg/m2 (N=3) n=3 participants at risk Alvocidib 30 mg/m2 bolus followed by 40 mg/m2 IV infusion over 4 hours	Alvocidib 30/50 mg/m2 (N=3) n=3 participants at risk Alvocidib 30 mg/m2 bolus followed by 50 mg/m2 IV infusion over 4 hours	Alvocidib 30/60 mg/m2 (N=23) n=23 participants at risk Alvocidib 30 mg/m2 bolus followed by 60 mg/m2 IV infusion over 4 hours
Cardiac disorders Cardiogenic shock	33.3% 1/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Fungaemia	33.3% 1/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Pneumonia	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Pneumonia fungal	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Sepsis	33.3% 1/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Septic shock	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Investigations Blood bilirubin increased	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Investigations Blood creatinine increased	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Haemorrhage intracranial	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	0.00% 0/3 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.	4.3% 1/23 • Beginning at 1st dose of study drug through 30 days of the last administration of study drug Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Other adverse events

Additional Information

Susan Smith

Sumitomo Dainippon Pharma Oncology, Inc.

Phone: 2104147702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place