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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 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.

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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

Carcinoma, Hepatocellular

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

FieldValue
Enrollment Target 14 participants
Start Date 2013-09-27
Est. Completion 2017-02-08
Phase Phase 2

Sponsor

Bayer

591 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01915602

The ClinicalTrials.gov registry entry for NCT01915602 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 612-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (98% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.