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

Trial details

Who runs it

Michael McHale

Trial code

NCT03287271

Record updated

2026. július 31.

Original description

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

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

Inclusion: 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: 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; Known second primary or prior malignancy diagnosed within 5 years of study start date (other than previously treated non-melanoma skin cancer); History of gastrointestinal fistula, hemorrhage, perforation or peptic ulcer disease; Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma; Patients who are pregnant or breastfeeding.

ClinicalTrials.gov NCT03287271