Trial Outcomes & Findings for Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194 (NCT NCT00820170)
NCT ID: NCT00820170
Last Updated: 2019-08-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
Through completion of Phase I, up to 1 year
Results posted on
2019-08-13
Participant Flow
Participant milestones
| Measure |
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
Participants Who Did Not Receive Treatment
Participants did not receive treatment
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
3
|
40
|
4
|
|
Overall Study
COMPLETED
|
3
|
5
|
3
|
40
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
Participants Who Did Not Receive Treatment
Participants did not receive treatment
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Progressive Disease
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Dasatinib In Combination With Weekly Paclitaxel For Patients With Metastatic Breast Carcinoma CA 180 194
Baseline characteristics by cohort
| Measure |
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg
n=3 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
n=5 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
n=3 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
n=4 Participants
No Treatment Arm Selected
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
56 years
n=7 Participants
|
59 years
n=5 Participants
|
50.7 years
n=4 Participants
|
52.5 years
n=21 Participants
|
51.89 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
55 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Through completion of Phase I, up to 1 yearPopulation: 15 participants were enrolled for the Phase I portion of the study. These 15 participants determined the MTD for the study.
Outcome measures
| Measure |
Dasatinib and Paclitaxel
n=15 Participants
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.
The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.
Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel.
|
120 mg of dasatinib
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through study completion, up to 2 yearsPopulation: The 3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study. Results and data analysis reflect this.
Outcome measures
| Measure |
Dasatinib and Paclitaxel
n=3 Participants
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.
The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.
Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
n=5 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
n=3 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
n=4 Participants
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial.
Not Evaluable for Response
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial.
Stable Disease
|
3 Participants
|
1 Participants
|
1 Participants
|
15 Participants
|
1 Participants
|
|
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial.
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial.
Partial Response
|
0 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
|
Efficacy (Objective Response Rate; ORR; Complete Response (CR) + Partial Response (PR)) of Dasatinib When Administered in Combination With Weekly Paclitaxel at the MTD Established During the Phase I Portion of This Trial.
Progression of Disease
|
0 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 2 yearsPopulation: This objective is specific for the Phase II participants
Overall Survival for Phase II Participants
Outcome measures
| Measure |
Dasatinib and Paclitaxel
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.
The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.
Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Median Overall Survival for Phase II Participants
|
—
|
—
|
—
|
20.6 months
Interval 12.9 to 25.2
|
—
|
SECONDARY outcome
Timeframe: Through study completion, up to 2 yearsPopulation: The 3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
Evaluate adverse events using CTCAE v3
Outcome measures
| Measure |
Dasatinib and Paclitaxel
n=3 Participants
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.
The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.
Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
n=40 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
n=5 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=3 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
n=4 Participants
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Participant Adverse Events to Measure Safety and Tolerability of Dasatinib When Administered in Combination With Weekly Paclitaxel.
|
3 Participants
|
40 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 2 yearsPopulation: This objective is specific for the Phase II participants
Per RECIST criteria, Progression (PD) is defined at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Dasatinib and Paclitaxel
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.
The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.
Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Median Progression Free Survival for Phase II Participants
|
—
|
—
|
—
|
5.2 months
Interval 2.9 to 9.9
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Phase II participants only
Tumor biomarker data obtained at baseline and after 2 cycles of treatment (8 weeks), will be performed by enzyme-linked immunosorbent assay. Clinical Benefit is defined as the sum of the percentage of participants who achieved CR, PR and stable disease for \> 6 months.
Outcome measures
| Measure |
Dasatinib and Paclitaxel
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.
The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.
Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Phase II: Number of Participants With Clinical Benefit According to Tumor Biomarker Data: Assays of VEGFR2
Discontinued prior to 1st Assessment
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Phase II: Number of Participants With Clinical Benefit According to Tumor Biomarker Data: Assays of VEGFR2
Clinical Benefit, VEGF collected
|
0 Participants
|
0 Participants
|
0 Participants
|
13 Participants
|
0 Participants
|
|
Phase II: Number of Participants With Clinical Benefit According to Tumor Biomarker Data: Assays of VEGFR2
No Clinical Benefit, VEGF Collected
|
0 Participants
|
0 Participants
|
0 Participants
|
19 Participants
|
0 Participants
|
|
Phase II: Number of Participants With Clinical Benefit According to Tumor Biomarker Data: Assays of VEGFR2
Clinical Benefit, VEGF Not Collected
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Phase II: Number of Participants With Clinical Benefit According to Tumor Biomarker Data: Assays of VEGFR2
No Clinical Benefit, VEGF Not Collected
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 2 yearsPopulation: This objective is specific for the Phase II participants
Outcome measures
| Measure |
Dasatinib and Paclitaxel
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.
The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.
Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Median Time To Progression for Phase II Participants
|
—
|
—
|
—
|
5.84 months
Interval 0.0 to 25.7
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Phase II participants only
Phase II participants only
Outcome measures
| Measure |
Dasatinib and Paclitaxel
The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.
The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.
Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:
Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 Participants
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Phase II: Number of Participants With Clinical Benefit According to Circulating Tumor Cells (CTC) at Baseline and After 2 Cycles of Treatment (8 Weeks)
Clinical Benefit, No CTC Collected
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase II: Number of Participants With Clinical Benefit According to Circulating Tumor Cells (CTC) at Baseline and After 2 Cycles of Treatment (8 Weeks)
Discontinued treatment prior to 1st assessment
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Phase II: Number of Participants With Clinical Benefit According to Circulating Tumor Cells (CTC) at Baseline and After 2 Cycles of Treatment (8 Weeks)
Clinical Benefit, CTC Collection
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
0 Participants
|
|
Phase II: Number of Participants With Clinical Benefit According to Circulating Tumor Cells (CTC) at Baseline and After 2 Cycles of Treatment (8 Weeks)
No Clinical Benefit, CTC Collection
|
0 Participants
|
0 Participants
|
0 Participants
|
20 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
Serious events: 11 serious events
Other events: 40 other events
Deaths: 5 deaths
No Arm Selected
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg
n=3 participants at risk
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
n=5 participants at risk
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
n=3 participants at risk
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 participants at risk
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
n=4 participants at risk
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia supraventricular
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased/Anemia
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
General disorders
Pain
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Laboratory test abnormal
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
Other adverse events
| Measure |
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 100 mg
n=3 participants at risk
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 100 mg daily continuously
|
Phase 1: Paclitaxel 80 mg/m2 + Dasatinib 150 mg
n=5 participants at risk
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 150 mg daily continuously
|
Phast 1: Paclitaxel 80 mg/m2 + Dasatinib 70 mg
n=3 participants at risk
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 70 mg daily continuously
|
Phase 2: Paclitaxel 80 mg/m2 + Dasatinib 120 mg
n=40 participants at risk
Paclitaxel 80 mg/m2 weekly 3/4; Dasatinib 120 mg daily continuously
|
No Arm Selected
n=4 participants at risk
No Treatment Arm Selected
|
|---|---|---|---|---|---|
|
Investigations
ALT, SGPT
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
15.0%
6/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Hyperbilirubinemia
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Creatinine
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
8/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
17.5%
7/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
60.0%
3/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
8/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
27.5%
11/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Gastrointestinal disorders
Heartburn/Dyspepsia
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
60.0%
3/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
47.5%
19/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
INR
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Infections and infestations
Infection, other
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
White Blood Cells/Leukocytes
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
60.0%
3/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
30.0%
12/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
10.0%
4/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Nervous system disorders
Neuropathy: sensory
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
10.0%
4/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Neutrophils/Granulocytes (ANC/AGC)
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
60.0%
3/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
35.0%
14/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
General disorders
Pain
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
10.0%
4/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
66.7%
2/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
27.5%
11/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Prolonged QTc interval
|
66.7%
2/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
7.5%
3/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
AST, SGOT
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
8/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Alkaline Phosphatase
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Cholesterol, high (hypercholestremia)
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
7.5%
3/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
General disorders
Fever
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
7.5%
3/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Lymphocytes
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
40.0%
2/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
27.5%
11/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
PTT
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
5.0%
2/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
7.5%
3/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Platelets
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
40.0%
2/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
2.5%
1/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
7.5%
3/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
7.5%
3/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Amylase
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
|
Investigations
Lipase
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
20.0%
1/5 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/3 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/40 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
0.00%
0/4 • Phase I: 1 year Phase II: 2 years
3 participants treated in the Phase I portion of the study at Paclitaxel 80mg/m2 + Dasatinib 120 mg were included in the group of 40 participants in the Phase II portion of this study.
|
Additional Information
Dr. Monica Fornier
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4563
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place