Sorafenib + Doxorubicin for Liver Cancer

Recruiting at 5 trial locations

Overseen by Ghassan Abou-Alfa, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out what effects, good and/or bad, the combination of the drug sorafenib in combination with the drug doxorubicin might have on the growth and spread of liver cancer (HCC).

Research Team

Ghassan Abou-Alfa, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with advanced liver cancer (HCC) who have seen their disease progress despite being treated with Sorafenib. They should not have severe cirrhosis, heart issues, or other serious illnesses and must not be pregnant. Prior treatments are allowed under certain conditions, but they can't have had systemic doxorubicin before.

Inclusion Criteria

Informed consent must be obtained prior to study initiation

Absolute neutrophil count (ANC) ≥1,500/μL

Expected survival of at least 3 months

Exclusion Criteria

Pregnancy or lactation

Participation in concurrent investigational studies

Uncontrolled inter-current illness or psychiatric illness or social situations that would limit compliance with study requirements

Treatment Details

Interventions

• Doxorubicin (Anti-tumor antibiotic)
• Sorafenib (Kinase Inhibitor)

Trial Overview The study tests the combination of two drugs: Sorafenib and Doxorubicin on liver cancer growth after previous treatment failure with just Sorafenib. It aims to understand the effects—both good and bad—of this drug duo on controlling cancer progression.

Participant Groups

Group I: Sorafenib plus Doxorubicin Experimental Treatment 2 Interventions

Doxorubicin 60 mg/m2 IV on Day 1 of each 3 weeks cycle until unacceptable toxicity Sorafenib 400 mg PO BID or last dose patient from previous sorafenib based therapy, until unacceptable toxicity or disease progression, after which sorafenib can be continued as a single agent.

Doxorubicin is already approved in Canada, Japan for the following indications:

Approved in Canada as Doxorubicin for:

• Breast cancer
• Ovarian cancer
• Bladder cancer
• Lymphomas
• Leukemias
• Multiple myeloma
• Kaposi's sarcoma
• Soft tissue sarcomas

Approved in Japan as Doxorubicin for:

• Breast cancer
• Ovarian cancer
• Bladder cancer
• Lymphomas
• Leukemias
• Multiple myeloma
• Kaposi's sarcoma
• Soft tissue sarcomas

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Crystal S. Denlinger

National Comprehensive Cancer Network

Chief Executive Officer since 2023

MD, FACP

Robert W. Carlson

National Comprehensive Cancer Network

Chief Medical Officer since 2013

MD