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

Sponsor

Indiana University School of Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT01348503

Collaborator

Celgene Corporation (Industry)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Lenalidomide Drug: Sorafenib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities as a Measure of Safety of the combination of lenalidomide and sorafenib. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University School of Medicine
Celgene Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Indiana University School of Medicine

ClinicalTrials.gov Identifier:

NCT01348503

Other Study ID Numbers:

1004-05; IUCRO-0298

First Posted:

May 5, 2011

Last Update Posted:

Aug 31, 2015

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Lenalidomide

Sorafenib

Study Results

No Results Posted as of Aug 31, 2015