Trial Outcomes & Findings for Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes (NCT NCT03222856)
NCT ID: NCT03222856
Last Updated: 2025-06-05
Results Overview
The efficacy -as determined by the clinical benefit rate (CBR) (total number of objective responses plus stable disease for at least 24 weeks) based on RECIST v.1.1- of MK3475 (pembrolizumab) in combination with eribulin in patients with HR-positive/HER2-negative MBC who have previously received an anthracycline and a taxane (for either early or advanced disease), unless contraindicated, and between one to two lines of chemotherapy in the metastatic setting. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a decrease of ≥30% in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as Progressive Disease (PD).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Through study completion. From baseline up to 36 months.
Results posted on
2025-06-05
Participant Flow
Between Dec 2017 and Oct 2018, a total of 44 patients with HR+ and HER2- MBC were enrolled at 11 sites. These patients were distributed into one arm and treated with pembrolizumab combinated with Eribulin.
Written informed consent. Females ≥18. ECOG status must be 0 or 1. Life expectancy ≥12 weeks. Patients have histologically and/or cytologically confirmed breast cancer. Radiologic evidence of inoperable lrMBC. HER2-negative breast cancer (by ISH or IHC) of 0,1+,2+. HR-positive BC with \>1% of tumor cells. Available tumor tissue for PD-L1 analysis.
Participant milestones
| Measure |
Pembrolizumab + Eribulin
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Eribulin
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Eribulin
n=44 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
52.50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion. From baseline up to 36 months.The efficacy -as determined by the clinical benefit rate (CBR) (total number of objective responses plus stable disease for at least 24 weeks) based on RECIST v.1.1- of MK3475 (pembrolizumab) in combination with eribulin in patients with HR-positive/HER2-negative MBC who have previously received an anthracycline and a taxane (for either early or advanced disease), unless contraindicated, and between one to two lines of chemotherapy in the metastatic setting. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR) is defined as the disappearance of all target lesions. Partial Response (PR) is defined as a decrease of ≥30% in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as Progressive Disease (PD).
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=44 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Efficacy of Pembrolizumab in Combination With Eribulin.
|
25 Participants
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.Population: Patients PD-L1 positive
CBR based on RECIST v.1.1 in subjects with PD-L1 positive tumors.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=21 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
The CBR in Subjects With Programmed Death Ligand-1 (PD-L1) Positive Tumors.
|
9 Participants
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.PFS based on RECIST v.1.1.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=44 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
The Progression-free Survival (PFS)
|
6.03 months
Interval 3.7 to 8.4
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.PFS based on RECIST v.1.1 in subjects with PD-L1 positive tumors.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=21 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
The PFS in Subjects With PD-L1 Positive Tumors.
|
5.27 months
Interval 2.47 to 6.37
|
SECONDARY outcome
Timeframe: From baseline up to 36 months.Overall survival (OS) represents the time from the start of the study until death from any cause.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=44 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Overall Survival (OS)
|
14.23 months
Interval 9.23 to
The upper limit is reported as Not Available (NA) due to insufficient events or censored data, making accurate estimation unreliable
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.OS in subjects with PD-L1 positive tumors.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=21 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
The OS in Subjects With PD-L1 Positive Tumors.
|
13.6 months
Interval 6.3 to 22.7
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.The Overall Response Rate (ORR) is defined as the proportion of participants who achieve a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST v1.1 criteria. ORR is calculated as: ORR = (Number of participants with CR + Number of participants with PR) / Total number of participants.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=44 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Overall Response Rate (ORR) Based on RECIST v1.1
|
18 Participants
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.The Overall Response Rate (ORR) in participants with PD-L1 positive tumors is defined as the proportion of participants with a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST v1.1 criteria. ORR is calculated as: ORR = (Number of participants with CR + Number of participants with PR) / Total number of participants with PD-L1 positive tumors.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=21 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Overall Response Rate (ORR) in Participants With PD-L1 Positive Tumors Based on RECIST v1.1
|
8 Participants
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.DoR based on RECIST v.1.1.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=44 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
The Duration of Response (DoR)
|
6.23 months
Interval 3.07 to
There were not enough events in the SOC arm (patients discharged) to estimate the upper limit of the 95% confidence interval.
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.DoR based on RECIST v.1.1 in subjects with PD-L1 positive tumors.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=21 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
The DoR in Subjects With PD-L1 Positive Tumors.
|
5.23 months
Interval 3.07 to
There were not enough events in the SOC arm (patients discharged) to estimate the upper limit of the 95% confidence interval.
|
SECONDARY outcome
Timeframe: Through study completion. From baseline up to 36 months.The safety and tolerability of MK3475 (pembrolizumab) in combination with eribulin according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.3.
Outcome measures
| Measure |
Pembrolizumab + Eribulin
n=44 Participants
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Number of AEs Per CTCAE Grade (Safety and Tolerability of Pembrolizumab in Combination With Eribulin)
Grade 1
|
424 number of AEs per CTCAE grade
|
|
Number of AEs Per CTCAE Grade (Safety and Tolerability of Pembrolizumab in Combination With Eribulin)
Grade 2
|
192 number of AEs per CTCAE grade
|
|
Number of AEs Per CTCAE Grade (Safety and Tolerability of Pembrolizumab in Combination With Eribulin)
Grade 3
|
50 number of AEs per CTCAE grade
|
|
Number of AEs Per CTCAE Grade (Safety and Tolerability of Pembrolizumab in Combination With Eribulin)
Grade 4
|
5 number of AEs per CTCAE grade
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsNew predictive factors of response to MK3475 (pembrolizumab) and eribulin
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsNew predictive factors of response to MK3475 (pembrolizumab) and eribulin
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion. From baseline up to 36 months.New predictive factors of response to MK3475 (pembrolizumab) and eribulin
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab + Eribulin
Serious events: 0 serious events
Other events: 44 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pembrolizumab + Eribulin
n=44 participants at risk
All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle. Treatment with MK3475 (pembrolizumab) and eribulin will continue based on physician criteria. No maximum duration of treatment is specified. Study follow-up will be performed 12 months after last study dose.
Pembrolizumab: MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
Eribulin: Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
45.5%
20/44 • Number of events 46 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
43.2%
19/44 • Number of events 32 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.5%
20/44 • Number of events 26 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
General disorders
Asthenia
|
43.2%
19/44 • Number of events 38 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
31.8%
14/44 • Number of events 30 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
General disorders
Fatigue
|
31.8%
14/44 • Number of events 27 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Nervous system disorders
Peripheral neuropathy
|
27.3%
12/44 • Number of events 22 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
11/44 • Number of events 18 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
22.7%
10/44 • Number of events 10 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Investigations
Aspartate aminotransferase increased
|
20.5%
9/44 • Number of events 10 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Gastrointestinal disorders
Constipation
|
20.5%
9/44 • Number of events 9 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
General disorders
Mucositis
|
20.5%
9/44 • Number of events 17 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Infections and infestations
Urinary tract infection
|
20.5%
9/44 • Number of events 18 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
8/44 • Number of events 14 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Nervous system disorders
Headache
|
18.2%
8/44 • Number of events 12 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.9%
7/44 • Number of events 12 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.9%
7/44 • Number of events 8 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.9%
7/44 • Number of events 12 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
General disorders
Pyrexia
|
15.9%
7/44 • Number of events 7 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.6%
6/44 • Number of events 7 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
5/44 • Number of events 5 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Endocrine disorders
Hypothyroidism
|
11.4%
5/44 • Number of events 6 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Musculoskeletal and connective tissue disorders
Lumbar pain
|
11.4%
5/44 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
5/44 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
5/44 • Number of events 10 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
6.8%
3/44 • Number of events 3 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Investigations
Blood albumin decreased
|
4.5%
2/44 • Number of events 2 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.8%
3/44 • Number of events 3 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Infections and infestations
Brochitis
|
4.5%
2/44 • Number of events 2 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Nervous system disorders
Dizziness
|
6.8%
3/44 • Number of events 4 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Nervous system disorders
Dysgeusia
|
6.8%
3/44 • Number of events 3 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
4/44 • Number of events 6 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.8%
3/44 • Number of events 4 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.1%
4/44 • Number of events 5 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
9.1%
4/44 • Number of events 5 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Eye disorders
Lacrimation increased
|
13.6%
6/44 • Number of events 6 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.4%
5/44 • Number of events 6 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
4/44 • Number of events 6 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
|
Investigations
Platelet count decreased
|
6.8%
3/44 • Number of events 3 • Safety and tolerability of all patients will be closely monitored throughout study treatment and the follow-up period using the NCI CTCAE v.4.0.3 (36 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place