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

NCT01348503 | Terminated Phase 1 DMC

• 1 other identifier: 1004-05; IUCRO-0298
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Dose Limiting Toxicities as a Measure of Safety of the combination of lenalidomide and sorafenib.

  2 years

Study Arms (1)

Open Label, Single Arm

EXPERIMENTAL

Dose escalation of lenalidomide in combination with sorafenib at standard doses in patients with advanced, unresectable hepatocellular carcinoma.

Drug: Lenalidomide; Drug: Sorafenib

Interventions

Lenalidomide DRUG

Escalating doses starting at 15 mg by mouth per day.

Open Label, Single Arm

Sorafenib DRUG

Fixed dose of 400 mg by mouth twice a day.

Open Label, Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Celgene Corporation: collaborator

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Shahda S, Loehrer PJ, Clark RS, Spittler AJ, Althouse SK, Chiorean EG. Phase I Study of Lenalidomide and Sorafenib in Patients With Advanced Hepatocellular Carcinoma. Oncologist. 2016 Jun;21(6):664-5. doi: 10.1634/theoncologist.2016-0071. Epub 2016 Jun 2.

  PMID: 27256874 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Lenalidomide; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• E. Gabriela Chiorean, MD

  Indiana University Melvin and Bren Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2014
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

US (1)