Clinical trial · Interventional
ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
NCT03287271CI-TRIAL-00120147terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to loss of funding
Summary
Brief summary (as posted)
The purpose of the study is to investigate the combination VS-6063, carboplatin, and paclitaxel. in the treatment of patients with ovarian cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| VS-6063 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
- description
- Defactinib (VS-6063) (200 mg) + Carboplatin/Paclitaxel
- interventionNames
- Drug: VS-6063
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
- description
- Defactinib (VS-6063) (400 mg) + Carboplatin/Paclitaxel
- interventionNames
- Drug: VS-6063
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (2)
- measure
- Dose-Limiting Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.