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Refametinib(BAY86-9766) in RAS Mutant Hepatocellular Carcinoma (HCC)
NCT01915589 · View on ClinicalTrials.gov ↗
Study Summary
This is a study to investigate the potential clinical benefit of refametinib 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 confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib 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 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 improves the response rate in this RAS mutation patient population.
Conditions Studied
Interventions
- DRUG Refametinib (BAY86-9766)
Study Locations (20)
Other
- — Graz
- — Bruxelles - Brussel
- — Bruxelles - Brussel
- — Charleroi
- — Ghent
- — Leuven
- — Prague
- — Clermont-Ferrand
- — Créteil
- — Lille
- — Marseille
- — Montpellier
- — Vandœuvre-lès-Nancy
Florida
- — Miami
- — Tampa
New York
- — New York
- — Rochester
District of Columbia
- — Washington D.C.
Baden-Wurttemberg
- — Heidelberg
Bavaria
- — München
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-09-16 |
| Est. Completion | 2014-10-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01915589
The ClinicalTrials.gov registry entry for NCT01915589 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Carcinoma, Hepatocellular appearing as the primary indexed condition, and to 1 intervention — of which Refametinib (BAY86-9766) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01915589 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01915589 about?
NCT01915589 is a clinical study titled "Refametinib(BAY86-9766) in RAS Mutant Hepatocellular Carcinoma (HCC)". This is a study to investigate the potential clinical benefit of refametinib 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. ...
What is the current status of trial NCT01915589?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2013-09-16. Estimated completion is 2014-10-08.
What conditions does trial NCT01915589 study?
This clinical trial studies the following conditions: Carcinoma, Hepatocellular. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01915589?
The interventions under investigation include: Refametinib (BAY86-9766) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01915589?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01915589 being conducted?
This trial has 20 study locations across District of Columbia, Florida, New York, Baden-Wurttemberg, Bavaria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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