Trial Outcomes & Findings for Doxorubicin HCL Liposome Injection (DOXIL) in Combination With Abraxane in Patients With Metastatic Breast Cancer (NCT NCT00442260)
NCT ID: NCT00442260
Last Updated: 2021-01-22
Results Overview
COMPLETED
PHASE1/PHASE2
2 participants
Patients will be restaged every 3 cycles or approximately every 9 weeks. At the time of restaging, patients will have their disease status classified as complete response (CR), partial response (PR), progressive disease (PD) or stable disease (SD)
2021-01-22
Participant Flow
PI is not available, thus the numbers presented are what was initially entered by research team. From data available, only two participants were enrolled; no information about these participants could be found.
Participant milestones
| Measure |
Abraxane Dose Escalation + Fixed Dose DOXIL
Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination.
DOXIL
Abraxane
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Doxorubicin HCL Liposome Injection (DOXIL) in Combination With Abraxane in Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Patients will be restaged every 3 cycles or approximately every 9 weeks. At the time of restaging, patients will have their disease status classified as complete response (CR), partial response (PR), progressive disease (PD) or stable disease (SD)Population: PI is not available, therefore, no data is available for reporting in this section.Efforts to retrieve data were unsuccessful.
Outcome measures
Outcome data not reported
Adverse Events
Abraxane Dose Escalation + Fixed Dose DOXIL
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Trials Compliance Coordinator
West Virginia Universtiy, WVCTSI
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place