Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma

August 28, 2015 updated by: Indiana University School of Medicine

A Phase I Open-label Dose-escalation Study With Lenalidomide in Combination With a Fixed Dose of Sorafenib for the Treatment of Hepatocellular Carcinoma

The purpose of this study is to evaluate the combination of Revlimid® (lenalidomide) and Nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical or pathological diagnosis of unresectable hepatocellular carcinoma (HCC) based on radiologic criteria, elevated alpha fetoprotein and/or tissue biopsy
  • All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study
  • Child-Pugh Liver Function Class A/B9
  • Eastern Cooperative Oncology Group (ECOG) performance status of </= 2 at study entry
  • Laboratory test results within protocol-specific ranges
  • Disease free of prior malignancies for >/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® (Revlimid is only available under a restricted distribution program called "RevAssist.")
  • Females of childbearing potential must have two negative pregnancy tests before starting lenalidomide and must agree to use two methods of birth control and submit to pregnancy tests throughout the study.
  • Able to take aspirin daily as prophylactic anticoagulation
  • Age >18 years at the time of signing the informed consent form
  • Life expectancy of at least 30 days

Exclusion Criteria:

  • No serious medical condition, laboratory abnormality, or psychiatric illness (including no evidence of hepatic encephalopathy) that would prevent the subject from signing the informed consent form
  • No pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide)
  • No patients who have undergone surgical resection or received chemotherapy, percutaneous ethanol injection, radiation therapy or chemoembolization within 30 days prior to commencement of the study
  • No condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • No use of any other experimental drug or therapy within 28 days of baseline
  • No known hypersensitivity to thalidomide
  • Patients who developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs will be excluded
  • No prior use of lenalidomide
  • No concurrent use of other anti-cancer agents or treatments
  • No known positivity for HIV or infectious hepatitis, type B-8/9 or C
  • No active infection not controlled effectively with antimicrobial or antiviral therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label, Single Arm
Dose escalation of lenalidomide in combination with sorafenib at standard doses in patients with advanced, unresectable hepatocellular carcinoma.
Drug: Lenalidomide
Escalating doses starting at 15 mg by mouth per day.
Drug: Sorafenib
Fixed dose of 400 mg by mouth twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Dose Limiting Toxicities as a Measure of Safety of the combination of lenalidomide and sorafenib.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University School of Medicine

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: E. Gabriela Chiorean, MD, Indiana University Melvin and Bren Simon Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

August 31, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1004-05; IUCRO-0298

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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