NCT03287271 ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
| NCT ID | NCT03287271 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Michael McHale |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2018-02-06 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2018-02-06 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Michael McHale
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT03287271 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03287271 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03287271 currently recruiting?
Yes, NCT03287271 is actively recruiting participants. Contact the research team at mtmchale@ucsd.edu for enrollment information.
Where is the NCT03287271 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT03287271 clinical trial?
NCT03287271 is sponsored by Michael McHale. The principal investigator is Michael McHale at University of California, San Diego. The trial plans to enroll 90 participants.
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