The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer. The study will evaluate whether this regimen is safe. The study will also evaluate whether the regimen can reduce the amount of cancerous cells in your body. If you agree, you will be treated with VS-6063 by mouth, as well as carboplatin and paclitaxel infusions. Carboplatin and paclitaxel are approved by the FDA for the treatment of ovarian cancer. VS-6063 is considered experimental because it is not approved by the FDA for the treatment of cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Phase 1: * First 3 patient cohort: VS-6063 200 mg PO twice daily * IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily, Phase 2: VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Phase 1: * First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle. * IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle. Phase 2: Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity.
Phase 1: * First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle. * IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle. Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity.
University of California San Diego
San Diego, California, United States
Dose-Limiting Toxicity
Safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)
Time frame: 28 days
Objective Response Rate (ORR)
Time frame: 4 years
To Assess the Toxicity and Adverse Event Profile of VS-6063 Plus Paclitaxel and Carboplatin Chemotherapy (Measured Via Adverse Events)
Time frame: 4 years
To Describe Health-related Quality-of-life (QoL) Outcomes of Patients Receiving VS-6063 Plus Paclitaxel and Carboplatin Chemotherapy. (Measured Via Questionnaire)
Time frame: 4 years
Progression Free Survival (PFS)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
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