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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03287271
• Other study ID #: 170517
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 6, 2018
• Est. completion date: October 2024

Study information

• Verified date: February 2023
• Source: University of California, San Diego
• Contact: Michael McHale, MD
• Phone: (858) 822-6275
• Email: mtmchale[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Michael McHale	Nine Girls Ask, Verastem, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events)	Measured Via Adverse Events	4 years
Primary	Objective response rate (ORR)	ORR by RECIST 1.1.	4 years
Secondary	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
Secondary	To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire)	Measured Via Questionnaire	4 years
Secondary	progression free survival (PFS)	PFS by RECIST 1.1.	4 years
Secondary	overall survival (OS)	OS by RECIST 1.1.	4 years