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| Name | Class |
|---|---|
| Verastem, Inc. | INDUSTRY |
| Nine Girls Ask | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Defactinib (VS-6063) +Carboplatin/Paclitaxel | Experimental | Defactinib (VS-6063) +Carboplatin/Paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VS-6063 | Drug | Phase 1:
Phase 2: VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events) | Measured Via Adverse Events | 4 years |
| Objective response rate (ORR) | ORR by RECIST 1.1. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events) | Measured Via Adverse Events | 4 years |
| To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire) |
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Inclusion Criteria:
Must have adequate:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael McHale, MD | Contact | (858) 822-6275 | mtmchale@ucsd.edu | |
| Alexandrea Cronin, MPH | Contact | (858) 822-3975 | aocronin@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael McHale | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | San Diego | California | 92023 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 12, 2026 | Jan 27, 2026 | 7 | ||
| Jul 6, 2026 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| C584510 | defactinib |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Paclitaxel | Drug | Phase 1:
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. |
|
|
| Carboplatin | Drug | Phase 1:
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. |
|
|
Measured Via Questionnaire |
| 4 years |
| progression free survival (PFS) | PFS by RECIST 1.1. | 4 years |
| overall survival (OS) | OS by RECIST 1.1. | 4 years |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |