ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
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|ClinicalTrials.gov Identifier: NCT03287271|
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : February 3, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: VS-6063 Drug: Paclitaxel Drug: Carboplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK|
|Actual Study Start Date :||February 6, 2018|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||October 2024|
|Experimental: Defactinib (VS-6063) +Carboplatin/Paclitaxel||
VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity.
Other Name: defactinib
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.
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.
- To assess the safety and tolerability of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events) [ Time Frame: 4 years ]Measured Via Adverse Events
- Objective response rate (ORR) [ Time Frame: 4 years ]ORR by RECIST 1.1.
- To assess the toxicity and adverse event profile of VS-6063 plus paclitaxel and carboplatin chemotherapy (Measured Via Adverse Events) [ Time Frame: 4 years ]Measured Via Adverse Events
- To describe health-related quality-of-life (QoL) outcomes of patients receiving VS-6063 plus paclitaxel and carboplatin chemotherapy. (Measured Via Questionnaire) [ Time Frame: 4 years ]Measured Via Questionnaire
- progression free survival (PFS) [ Time Frame: 4 years ]PFS by RECIST 1.1.
- overall survival (OS) [ Time Frame: 4 years ]OS by RECIST 1.1.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287271
|Contact: Michael McHale, MD||(858) firstname.lastname@example.org|
|Contact: Alexandrea Cronin, MPH||(858) email@example.com|
|United States, California|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92023|
|Contact: Alexandrea Cronin, MPH 858-822-3975 firstname.lastname@example.org|
|Principal Investigator:||Michael McHale||University of California, San Diego|
|Responsible Party:||Michael McHale, Clinical Professor, University of California, San Diego|
|Other Study ID Numbers:||
|First Posted:||September 19, 2017 Key Record Dates|
|Last Update Posted:||February 3, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
primary peritoneal carcinoma
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action