HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)

NCT01849588 | Terminated Phase 4 Results

• 1 other identifier: 12-213
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief Summary

This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases. Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors. The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.

Conditions

Hepatocellular Cancer

Keywords

Hepatitis C positive

Outcome Measures

Primary Outcomes (1)

• Decline in HCV-RNA Level

  Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.

  up to 2 years

Secondary Outcomes (2)

• Time to Radiological Tumor Progression

  2 years

• Overall Survival

  2 years

Other Outcomes (1)

• Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Sorafenib taken orally twice per day

Drug: Sorafenib

Interventions

Sorafenib DRUG

Also known as: Nexavar

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Histologically and/or radiologically confirmed advanced HCC
• Detectable HCV RNA with anti-HCV-positivity
• Life expectancy of at least 3 months
• Willing to use adequate contraception

You may not qualify if:

• Pregnant or breastfeeding
• Undetectable HCV RNA
• Uncontrolled hypertension
• Active or clinically significant cardiac disease
• Thrombolic, embolic, venous or arterial events within 6 months of informed consent
• Pulmonary hemorrhage/bleeding event (NCI-CTCAE grade 2 or higher) within 4 weeks before study entry
• Previously untreated or concurrent cancer except cervical cancer in situ, treated basal cell carcinoma or superficial bladder tumor
• Presence of non-healing wound, ulcer or bone fracture
• History of organ allograft
• Known or suspected allergy or hypersensitivity to any of the study drugs
• Any malabsorption condition
• Inability to comply with the protocol and/or not willing or not available for follow up
• Major surgery within 30 days prior to start of study drug

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Study was terminated early due to slow accrual, therefore a small number of participants were analyzed and the data are not statistically significant.

Results Point of Contact

• Title: Dr. Andrew Zhu
• Organization: Massachusetts General Hospital

azhu@partners.org

617-724-4000

Study Officials

• Andrew Zhu, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 19, 2017
• Results First Posted: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)