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NCT02642913 · ClinicalTrials.gov registry record · Phase 1
Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02642913: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02642913 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02642913, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety of enzalutamide with or without sorafenib at different doses. Enzalutamide is approved by the Food and Drug Administration (FDA) for the treatment of advanced prostate cancer. Enzalutamide blocks a protein called the androgen receptor. Experiments on liver cancer cells and animal models show that blocking the androgen receptor causes liver cancer to stop growing. Enzalutamide has not been approved to treat liver cancer. The investigators want to see if enzalutamide is safe for patients with liver cancer who have had their tumors grow on sorafenib. The investigators also want to see how safe and effective sorafenib and enzalutamide are for liver cancer patients that have never been treated with sorafenib. This is the first time enzalutamide and sorafenib are being used together. This treatment may not help treat the participant's cancer.
Primary Outcome
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.
Interventions
- DRUG Enzalutamide
- DRUG Enzalutamide with Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-12 |
| Est. Completion | 2021-03-01 |
| Phase | Phase 1 |
What the finished NCT02642913 record still lists
NCT02642913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Enzalutamide is the first listed.
NCT02642913 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02642913 about?
NCT02642913 is a clinical study titled "Study of Enzalutamide With and Without Sorafenib in Advanced Hepatocellular Carcinoma Patients". The purpose of this study is to test the safety of enzalutamide with or without sorafenib at different doses. Enzalutamide is approved by the Food and Drug Administration (FDA) for the treatment of advanced prostate cancer. Enzalutamide blocks a protein called the androgen receptor. Experiments on l...
What is the current status of trial NCT02642913?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-12. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT02642913?
The interventions under investigation include: Enzalutamide (DRUG), Enzalutamide with Sorafenib (DRUG).
Who is sponsoring clinical trial NCT02642913?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02642913's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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