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NCT01915602 · ClinicalTrials.gov registry record · Phase 2
Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC)
A Phase 2 study of Carcinoma, Hepatocellular, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 20
- Study locations
NCT01915602: Completed Phase 2 study of Carcinoma, Hepatocellular, sponsored by Bayer.
NCT01915602 is a Phase 2 study of Carcinoma, Hepatocellular that has completed, run by Bayer. The registered enrollment target is 14 participants, below the 612-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915602, a Phase 2 study of Carcinoma, Hepatocellular, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement \[modified response evaluation criteria in solid tumors (mRECIST)\] assessed by external independent radiologists. Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.
Conditions Studied
Interventions
- DRUG Refametinib (BAY86-9766)
- DRUG Sorafenib (BAY43-9006)
Study Locations (20)
Other
- - Vienna
- - Bruxelles - Brussel
- - Edegem
- - Leuven
- - Liège
- - Beijing
- - Shanghai
- - Hradec Králové
- - Olomouc
- - Bordeaux
- - Caen
- - Lyon
- - Marseille
- - Nice
- - Paris
- - Saint-Priest-en-Jarez
- - Vandœuvre-lès-Nancy
Kentucky
- - Louisville
Guangdong
- - Guangzhou
Baden-Wurttemberg
- - Heidelberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-09-27 |
| Est. Completion | 2017-02-08 |
| Phase | Phase 2 |
What the finished NCT01915602 record still lists
NCT01915602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 612-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Carcinoma, Hepatocellular appearing as the primary indexed condition, and to 2 interventions - of which Refametinib (BAY86-9766) is the first listed.
NCT01915602 names 20 study sites across 4 states, led by Other, Kentucky, Guangdong.
Frequently Asked Questions
What is clinical trial NCT01915602 about?
NCT01915602 is a clinical study titled "Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC)". This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80...
What is the current status of trial NCT01915602?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2013-09-27. Estimated completion is 2017-02-08.
What conditions does trial NCT01915602 study?
This clinical trial studies the following conditions: Carcinoma, Hepatocellular.
What interventions are being tested in trial NCT01915602?
The interventions under investigation include: Refametinib (BAY86-9766) (DRUG), Sorafenib (BAY43-9006) (DRUG).
Who is sponsoring clinical trial NCT01915602?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01915602 being conducted?
This trial has 20 study locations across Kentucky, Guangdong, Baden-Wurttemberg. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01915602's enrollment target sits among peer trials
14 25th of 27 higher than 2 of 27 other Carcinoma, Hepatocellular trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Hepatocellular 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.
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