ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK

NCT ID: NCT03287271

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2026-04-30

Brief Summary

The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.

Detailed Description

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Defactinib (VS-6063) +Carboplatin/Paclitaxel

Defactinib (VS-6063) +Carboplatin/Paclitaxel

Group Type: EXPERIMENTAL

VS-6063

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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.

Interventions

VS-6063

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.

Intervention Type: DRUG

Paclitaxel

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.

Intervention Type: DRUG

Carboplatin

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.

Intervention Type: DRUG

Other Intervention Names

defactinib; Taxol; Paraplatin

Eligibility Criteria

Inclusion Criteria

• Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, diagnosed within 6 months of completing their most recent platinum-containing chemotherapy.
• Patients with the following histologic cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
• Must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, noncytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
• Must have NOT received more than two total prior lines of cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens.
• May have received one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition: Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small molecule inhibitors of signal transduction.
• Women of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception.

Must have adequate:

• Bone marrow function
• Renal function
• Hepatic function
• Neurologic function
• Recovered from effects of recent surgery, radiotherapy, or chemotherapy. All persistent clinically significant toxicities from prior chemotherapy must be less than or equal to Grade 1.
• Free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.

Exclusion Criteria

• Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma.
• Known second primary or prior malignancy diagnosed within 5 years of study start date (other than previously treated non-melanoma skin cancer).
• Current treatment with chemotherapy or radiation therapy. Any prior therapy directed at the malignant tumor, including biologic and immunologic agents, must be discontinued at least three weeks prior to registration.
• History of treatment with known kinase inhibiting agents.
• History of gastrointestinal fistula, hemorrhage, perforation or peptic ulcer disease.
• Patients who are pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Verastem, Inc.

INDUSTRY

Sponsor Role: collaborator

Nine Girls Ask

UNKNOWN

Sponsor Role: collaborator

Michael McHale

OTHER

Sponsor Role: lead

Responsible Party

Michael McHale

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael McHale

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael McHale, MD

Role: CONTACT

mtmchale@ucsd.edu

(858) 822-6275

Alexandrea Cronin, MPH

Role: CONTACT

aocronin@health.ucsd.edu

(858) 822-3975

Facility Contacts

Alexandrea Cronin, MPH

Role: primary

aocronin@health.ucsd.edu

858-822-3975

Other Identifiers

170517

Identifier Type: -

Identifier Source: org_study_id