Trial Outcomes & Findings for Trial of Dasatinib Plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer (NCT NCT00924352)
NCT ID: NCT00924352
Last Updated: 2014-10-13
Results Overview
The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
MTD was assessed during the first cycle of combination therapy (days 1-28).
Results posted on
2014-10-13
Participant Flow
The Phase I portion of this study was conducted at 4 oncology clinics located in the United States. The Phase II portion of the study was conducted at the 4 Phase I sites, plus 10 additional oncology clinics located in the United States. Enrollment started in July 2009 and was completed in June 2012.
Informed consent was obtained from all subjects. All subjects underwent screening procedures to verify eligibility.
Participant milestones
| Measure |
Phase I
The Phase I sample includes patients who were enrolled into the Phase I portion of this study. Patients received treatment according to the assigned dose level. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
|
Phase II
The Phase II sample includes patients who were enrolled into the Phase II portion of this study. Dasatinib and ixabepilone were administered at the maximum tolerated dose determined during the Phase I portion: dasatinib 100 mg daily and ixabepilone 20 mg/m2. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
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|---|---|---|
|
Overall Study
STARTED
|
12
|
44
|
|
Overall Study
COMPLETED
|
12
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Dasatinib Plus Ixabepilone in 2nd or 3rd Line Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone + Dasatinib
n=56 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
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|---|---|
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Age, Continuous
|
53.7 years
STANDARD_DEVIATION 9.29 • n=39 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: MTD was assessed during the first cycle of combination therapy (days 1-28).Population: The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.
The MTD of dasatinib (taken daily, continuously) when given in combination with ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.
Outcome measures
| Measure |
Ixabepilone + Dasatinib
n=12 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
Ixabepilone + Dasatinib (Dose Level 1)
Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
Ixabepilone + Dasatinib (Dose Level 2)
Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|
|
Determination of the Maximum Tolerated Dose (MTD) of Dasatinib When Given in Combination With Ixabepilone (Phase I)
|
100 mg daily
|
—
|
—
|
PRIMARY outcome
Timeframe: MTD was assessed during the first cycle of combination therapy (days 1-28).Population: The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.
The MTD of ixabepilone (administered on Days 1, 8, and 15 of a 28-day cycle) when given in combination with dasatinib (taken daily, continuously) was determined using a standard 3 + 3 dose escalation cohort design. The total sample and the number of patients who receive each dose in this design depends on the frequency of dose limiting toxicities (DLT) at each dosage. The MTD was defined as the dose at which ≤ 1 of 6 patients experienced DLT, and above which ≥ 2 of 6 patients experienced DLT.
Outcome measures
| Measure |
Ixabepilone + Dasatinib
n=12 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
Ixabepilone + Dasatinib (Dose Level 1)
Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
Ixabepilone + Dasatinib (Dose Level 2)
Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|
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Determination of the Maximum Tolerated Dose (MTD) of Ixabepilone When Given in Combination With Dasatinib (Phase I)
|
20 mg/m2
|
—
|
—
|
PRIMARY outcome
Timeframe: DLTs were assessed during the first cycle of combination therapy (days 1-28).Population: The Phase I analysis sample includes the 12 patients who were enrolled into the Phase I portion of the study.
DLTs were assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose limiting toxicity was defined as any grade 4 hematologic event or any grade 3 or 4 non-hematologic event occurring during cycle 1 that is attributable to dasatinib, ixabepilone, or the combination. The following events were excluded from this definition: grade 4 neutropenia lasting for 3 days or less; grade 3 nausea responsive to antiemetics; grade 3 infection with normal ANC or grade 1 or 2 neutrophils; grade 3 diarrhea responsive to optimal use of antidiarrheal therapy.
Outcome measures
| Measure |
Ixabepilone + Dasatinib
n=3 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
Ixabepilone + Dasatinib (Dose Level 1)
n=6 Participants
Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
Ixabepilone + Dasatinib (Dose Level 2)
n=3 Participants
Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|
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Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I)
DLT: Grade 4 Thrombocytopenia
|
0 participants
|
0 participants
|
1 participants
|
|
Determination of the Dose Limiting Toxicities (DLTs) of the Combination of Dasatinib and Ixabepilone (Phase I)
DLT: Grade 4 Leukopenia
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: PFS was measured from day 1 of treatment until time of progression (assessed about every 8 weeks) or death, whichever came first, for up to 27.2 months.Population: The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.
Disease progression was determined through radiology imaging measurements and by clinical or symptomatic progression during or after treatment. Progression is defined per RECIST v1.0 guidelines as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
Ixabepilone + Dasatinib
n=50 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
Ixabepilone + Dasatinib (Dose Level 1)
Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
Ixabepilone + Dasatinib (Dose Level 2)
Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|
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Evaluation of Progression-free Survival (PFS) of the Combination of Dasatinib and Ixabepilone (Phase II)
|
6.01 months
Interval 2.92 to 8.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.Population: The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.
Best overall response is defined as the best response across all time points. Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of \>=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.
Outcome measures
| Measure |
Ixabepilone + Dasatinib
n=50 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
Ixabepilone + Dasatinib (Dose Level 1)
Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
Ixabepilone + Dasatinib (Dose Level 2)
Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|
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Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)
Complete Response
|
0 participants
|
—
|
—
|
|
Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)
Partial Response
|
4 participants
|
—
|
—
|
|
Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)
Stable Disease
|
11 participants
|
—
|
—
|
|
Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)
Progressive Disease
|
23 participants
|
—
|
—
|
|
Best Overall Response of the Combination of Dasatinib and Ixabepilone (Phase II)
Not Evaluable
|
12 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Response to treatment was assessed after about every 8 weeks of treatment, for up to 27.2 months.Clinical benefit rate was defined as the percentage of participants experiencing stable disease (SD) of at least 24 weeks (from the start of treatment) plus complete response (CR) and partial response (PR). Response was evaluated via changes from baseline in radiological tumor measurements performed after every two treatment cycles and at the end of treatment or time of progression. Response was evaluated using RECIST version 1.0 guidelines, where CR is the disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter(LD) of target lesions; SD is neither sufficient shrinkage in sum of longest diameter of target lesions to be PR nor increase of \>=20%.
Outcome measures
| Measure |
Ixabepilone + Dasatinib
n=50 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
Ixabepilone + Dasatinib (Dose Level 1)
Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
Ixabepilone + Dasatinib (Dose Level 2)
Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|
|
Clinical Benefit Rate of the Combination of Dasatinib and Ixabepilone (Phase II)
|
26.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.Population: The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.
All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Outcome measures
| Measure |
Ixabepilone + Dasatinib
n=50 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
Ixabepilone + Dasatinib (Dose Level 1)
Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
Ixabepilone + Dasatinib (Dose Level 2)
Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|
|
Incidence of Grade 3 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)
|
31 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Adverse events were collected beginning on day 1 of treatment until one month after the end of study treatment.Population: The Phase II analysis sample of 50 patients includes the 6 patients from the Phase I portion of the study who were treated at the MTD as well as the 44 patients who were enrolled into the Phase II portion of the study.
All treatment emergent adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Outcome measures
| Measure |
Ixabepilone + Dasatinib
n=50 Participants
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
Ixabepilone + Dasatinib (Dose Level 1)
Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
Ixabepilone + Dasatinib (Dose Level 2)
Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|
|
Incidence of Grade 4 Adverse Events (AEs) With the Combination of Dasatinib and Ixabepilone (Phase II)
|
5 participants
|
—
|
—
|
Adverse Events
Ixabepilone + Dasatinib
Serious events: 11 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone + Dasatinib
n=56 participants at risk
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Chest Pain
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Edema due to Cardiac Disease
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Cellulitis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Skin Infection
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Electrocardiogram QT Prolonged
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
QT Prolonged
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
Other adverse events
| Measure |
Ixabepilone + Dasatinib
n=56 participants at risk
Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level - 1;100 mg QD,Dose Level - 2;70 mg QD.
Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.
Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level - 1;12 mg/m2,Dose Level - 2;12 mg/m2.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
51.8%
29/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.7%
20/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
8/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Blood and lymphatic system disorders
White Blood Cell Disorder
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Cardiac disorders
Palpitations
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Cardiac disorders
Sinus Tachycardia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Ear and labyrinth disorders
Ear Pain
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Eye Irritation
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Eyelid Edema
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Eye disorders
Vision Blurred
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
7/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
17.9%
10/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
55.4%
31/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Hematochezia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
53.6%
30/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
39.3%
22/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Asthenia
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Chest Pain
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Chills
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Fatigue
|
60.7%
34/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Generalized Edema
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Influenza-like Illness
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Infusion-related Reaction
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Injection Site Pain
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Localized Edema
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Malaise
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Mucosal Inflammation
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Mucosal Ulceration
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Myalgia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Nodule
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Edema
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Edema Peripheral
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Pain
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
General disorders
Pyrexia
|
14.3%
8/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Immune system disorders
Cytokine Release Syndrome
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Breast Infection
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Candidiasis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Cellulitis
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Eye Infection
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Herpes Zoster
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Nail infection
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Oral Candidiasis
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Rhinitis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Sinusitis
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Tooth Abscess
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion-related Reaction
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Injury, poisoning and procedural complications
Wound Complication
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Blood Creatinine Increased
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Electrocardiogram QT Prolonged
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Hemoglobin Decreased
|
10.7%
6/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Neutrophil Count
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Neutrophil Count Decreased
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Platelet Count Decreased
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
QT Prolonged
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
Weight Decreased
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
White Blood Cell Count
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Investigations
White Blood Cell Count Decreased
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
30.4%
17/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.7%
6/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.7%
6/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.2%
13/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
8/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.9%
5/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular Neoplasm
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Amnesia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Dizziness
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
32.1%
18/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Headache
|
30.4%
17/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Hypoesthesia
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Migraine
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Neuralgia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Neuropathy Peripheral
|
35.7%
20/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Paresthesia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Photophobia
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Somnolence
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Nervous system disorders
Syncope
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Psychiatric disorders
Anxiety
|
12.5%
7/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Psychiatric disorders
Confusional State
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Psychiatric disorders
Depression
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Psychiatric disorders
Insomnia
|
12.5%
7/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Psychiatric disorders
Mood Altered
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Psychiatric disorders
Restlessness
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Hematuria
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Micturition Urgency
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Reproductive system and breast disorders
Breast Pain
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Reproductive system and breast disorders
Nipple Pain
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal Pruritus
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.1%
18/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.1%
9/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea Exertional
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
7.1%
4/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
21.4%
12/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Exfoliative Rash
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair Disorder
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair Growth Abnormal
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.4%
12/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Generalized
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Epistaxis
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Hypertension
|
5.4%
3/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Hypotension
|
1.8%
1/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
|
Vascular disorders
Lymphedema
|
3.6%
2/56 • Adverse events were collected on day 1 of treatment until one month after the end of study treatment.
|
Additional Information
Vice President of Scientific Affairs
Vector Oncology (formerly Accelerated Community Oncology Research Network, Inc.)
Phone: 901-435-5570
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The funder will be provided with a copy of the proposed publication at least 30 days prior to its submission or presentation. The funder may request the presentation/submission be delayed for an additional 90 days to allow the funder to seek patent protection. The funder can require the deletion of information deemed as confidential.
- Publication restrictions are in place
Restriction type: OTHER