Combination of Carboplatin, Eribulin Mesylate, and E7449 in BRCA-Related Cancers
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|ClinicalTrials.gov Identifier: NCT02396433|
Recruitment Status : Withdrawn (lack of funding.)
First Posted : March 24, 2015
Last Update Posted : August 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Breast||Drug: Carboplatin Drug: Eribulin Drug: E7449||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Clinical Trial of the Combination of Carboplatin, Eribulin Mesylate, and E7449 in Patients With BRCA-Related Cancers|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Carboplatin, eribulin, and E7449
This is a phase I/II clinical trial of the combination of carboplatin, eribulin, and E7449.
Carboplatin will be given on day 1 of each cycle.
Other Name: Paraplatin
Eribulin will be given on days 1 and 8 of each cycle.
Other Name: Halaven
E7449 will be given daily (days 1-21) during each cycle. Patients will continue to receive treatment until progression of disease or discontinuation due to unacceptable side effects.
Other Name: PARP inhibitor
- Safety of E7449 will be measured by the number, frequency and severity of adverse events. [ Time Frame: Baseline to 24 months ]Patients will be evaluated by MD at clinic visits during Cycle 1, on Day 1 of all 21-day cycles, and will have additional evaluations if clinically indicated.
- MTD (maximum tolerated dose) of E7449 will be measured by the number, frequency and severity of adverse events. [ Time Frame: Baseline to 21 days ]Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of non-hematologic DLT (dose limiting toxicity) is defined as any Grade ≥ 3 toxicity, and a hematologic DLT is defined as any Grade ≥ 4 toxicity, both by CTCAE v 4.03 criteria.
- Overall response rate will be measured by the evaluation of target and non-target lesions for changes in tumor measurements. [ Time Frame: Baseline to first occurrence of disease progression or death. (up to 6 weeks) ]The overall response rate (ORR) will be defined as response after scans (CT or MRI) assessed after two cycles of therapy (1 cycle = 3 weeks).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396433
|Principal Investigator:||Virginia Kaklamani||UTHSCSA@CTRC|