Combining VS-6063 with carboplatin and paclitaxel for ovarian cancer treatment
ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
This study is testing if a new drug called VS-6063, when combined with two common chemotherapy drugs, can help women with recurring ovarian cancer feel better and fight the disease more effectively.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT03287271 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of a treatment regimen combining the experimental drug VS-6063 with the FDA-approved chemotherapy agents carboplatin and paclitaxel in patients with recurrent or persistent ovarian cancer. Participants will receive VS-6063 orally, along with infusions of carboplatin and paclitaxel, to evaluate whether this combination can effectively reduce cancerous cells in the body. The trial aims to provide insights into the potential re-sensitization of carboplatin-resistant ovarian cancer using this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include those with recurrent or persistent epithelial ovarian cancer who have recently completed platinum-based chemotherapy.
Not a fit: Patients who have received more than two lines of cytotoxic chemotherapy for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for patients with carboplatin-resistant ovarian cancer.
How similar studies have performed: Other studies have explored similar combinations of chemotherapy and targeted therapies, showing promising results, but this specific approach is considered novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California
- University of California San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Michael McHale — University of California, San Diego
- Study coordinator: Michael McHale, MD
- Email: mtmchale@ucsd.edu
- Phone: (858) 822-6275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.