Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients
|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: NCT02642913|
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Enzalutamide Drug: Enzalutamide with Sorafenib||Phase 1 Phase 2|
This is a multicenter, open label, phase I/II study of enzalutamide with or without sorafenib to define the safety, MTD, and pharmacokinetic parameters of each regimen in advanced HCC patients.
The study will have 4 parts as indicated in the Study Schema, an enzalutamide dose escalation (Part 1A), a sorafenib and enzalutamide dose escalation (Part 1B), and dose expansion cohorts for the Part 1A and Part 1B MTDs (Part 2). Dose escalation will occur using a standard 3 + 3 design and is described in Section 4.2.1. For Part 2, the enzalutamide expansion cohort (Part 2A), will enroll 10 patients and is exploratory in nature; however, it will allow for acquisition of additional PK sampling at the MTD, for determination of safety and efficacy. The MTD sorafenib and enzalutamide combination expansion (Part 2B) will be designed using a Simon minimax design to formally evaluate the 4-month PFS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||73 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase I/II Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Enzalutamide without Sorafenib
Will get enzalutamide, at the dose approved by the FDA for prostate cancer. If this dose has serious side effects, a lower dose will be given to new patients as they take part in the study. At the end of this part of the study, the recommended dose of enzalutamide will be set for all patients on this study. More patients will then be treated with this dose.
Experimental: Enzalutamide with Sorafenib
Will get enzalutamide and sorafenib. The first group of patients will get the recommended dose of enzalutamide with sorafenib by mouth either once or twice daily. The dose of sorafenib you receive will depend on when the patient starts the study. At the beginning of the study, patients will be treated with a lower dose of sorafenib. If this dose does not have serious side effects, a higher dose will be given to new patients as they take part in the study.
|Drug: Enzalutamide Drug: Enzalutamide with Sorafenib|
- Progression-free survival [ Time Frame: 4 months ]survival is defined as the time from the initiation of study treatment to HCC radiographic progression or death. Four month PFS is defined as the proportion of patients alive and progression free at 4 months. Patients that come out of study before evaluation of the 4 month endpoint without documented progression will be considered as events for the primary endpoint of 4 month PFS. Progression will be 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): NCT02642913
|Contact: James Harding, MD||646-888-4314|
|Contact: Ghassan Abou-Alfa, MD||646-888-4184|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Robin K Kelley, MD 415-353-9888|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Benjamin Tan, MD 314-747-7222|
|Principal Investigator: Benjamin Tan, MD|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263-0001|
|Contact: Iyer Renuka, MD 716-845-2300|
|Memorial Sloan Kettering Westchester||Recruiting|
|Harrison, New York, United States, 10604|
|Contact: James Harding, MD 646-888-4314|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: James Harding, MD 646-888-4314|
|Contact: Ghassan Abou-Alfa, MD 646-888-4184|
|Principal Investigator:||James Harding, MD||Memorial Sloan Kettering Cancer Center|