ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03287271|
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : January 27, 2020
|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.
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: Rachel O'Connoremail@example.com|
|United States, California|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92023|
|Contact: Sara Neugroschl 858-822-7952|
|Principal Investigator:||Michael McHale||University of California, San Diego|