Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03032614|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : January 26, 2017
Last Update Posted : October 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Stage IV Ovarian Cancer BRCA1 Mutation BRCA2 Mutation||Drug: Carboplatin Drug: Eribulin Drug: Veliparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial on the Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients With Homologous Recombination Deficiency|
|Estimated Study Start Date :||September 30, 2017|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||April 30, 2020|
Experimental: Combination of Carboplatin, Eribulin, and Veliparib
Eribulin will be administered intravenously (IV) on days 1 and 8 of each cycle at a dose of 1.1 mg/m2 over a 2-5 minute time period; on cycle day 1. Carboplatin will be administered intravenously at a dose of AUC 5 on day 1 of each cycle, over 30 min, immediately following eribulin infusion, per institutional guidelines. Veliparib will be given at 120 mg bid (two times a day), on days 2-12 for the first cycle of the safety run-in period and thereafter at 240 mg bid.
Carboplatin is a second generation tetravalent organic platinum compound. Similar to cisplatin, carboplatin produces predominantly interstrand DNA crosslinks as opposed to DNA-protein crosslinks. Carboplatin is cell-cycle non-specific.
Other Name: Paraplatin
Eribulin Mesylate is a synthetic halichondrin analog.
Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapeutics.
Other Name: ABT-888
- Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03) [ Time Frame: Approximately 1.5 years ]Graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)
- Tumor response assessed using RECIST 1.1 guidelines [ Time Frame: Measured every 6 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year ]Response will be assessed in this study via physical exam and imaging.
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): NCT03032614
|Principal Investigator:||Virginia Kaklamani, MD||UT Health San Antonio|