Trial Outcomes & Findings for Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer (NCT NCT00622466)
NCT ID: NCT00622466
Last Updated: 2020-10-19
Results Overview
Progression-free survival was defined as the time of treatment to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment. Tenth month of progression-free rate of sorafenib and paclitaxel will be compared agains the null progression free rate of 32% using normal approximation test.
TERMINATED
PHASE2
20 participants
Time from first treatment to disease progression or death (up to 36 months)
2020-10-19
Participant Flow
Participant milestones
| Measure |
Sorfenib + Paclitaxel
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Sorfenib + Paclitaxel
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Sorfenib + Paclitaxel
n=20 Participants
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from first treatment to disease progression or death (up to 36 months)Progression-free survival was defined as the time of treatment to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment. Tenth month of progression-free rate of sorafenib and paclitaxel will be compared agains the null progression free rate of 32% using normal approximation test.
Outcome measures
| Measure |
Sorfenib + Paclitaxel
n=16 Participants
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
|
|---|---|
|
Time to Tumor Progression
|
6.6 months
Interval 4.5 to 7.5
|
SECONDARY outcome
Timeframe: Up to 36 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. The confirmed response rate was estimated by the number of confirmed responses divided by the total number of participants randomized.
Outcome measures
| Measure |
Sorfenib + Paclitaxel
n=16 Participants
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
|
|---|---|
|
Tumor Response Rate
|
18.75 % of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This data were not collected.
The proportion of patients with progression-free survival at 6 months. Progression-free is measured from Day-1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Sole Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as 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 leasions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: This data were not collected.
Number of patients experiencing treatment failure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: This data were not collected.
Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions for at least 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: This data were not collected.
Number weeks until disease progression measured from Day-1 of study drug administration to disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: This data were not collected.
Number of patients without experiencing treatment-related adverse events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: This data were not collected.
Median values taken for all assays at baseline and relationship to response vs. no response will be made to identify predictive markers using methods to detect differential expression between two groups samples, including variants of the two-sample t-test, analysis of variance, F-test, and the Wilcoxon rank-sum test.
Outcome measures
Outcome data not reported
Adverse Events
Sorfenib + Paclitaxel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sorfenib + Paclitaxel
n=16 participants at risk
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
paclitaxel: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
sorafenib tosylate: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
|
|---|---|
|
Infections and infestations
Gangrene wound
|
6.2%
1/16 • Number of events 1 • Weekly until end of study, as average of up to 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Weekly until end of study, as average of up to 36 months
|
|
General disorders
Fatigue
|
12.5%
2/16 • Number of events 2 • Weekly until end of study, as average of up to 36 months
|
|
Infections and infestations
Hand-foot
|
31.2%
5/16 • Number of events 5 • Weekly until end of study, as average of up to 36 months
|
|
Cardiac disorders
Hypertension
|
6.2%
1/16 • Number of events 1 • Weekly until end of study, as average of up to 36 months
|
|
Gastrointestinal disorders
Nausea/vomiting
|
6.2%
1/16 • Number of events 1 • Weekly until end of study, as average of up to 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Asymptomatic pulmonary emboli
|
12.5%
2/16 • Number of events 2 • Weekly until end of study, as average of up to 36 months
|
Additional Information
Dr. Barbara Haley
The University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place