Trial of Sorafenib in Hepatocellular Cancer (HCC) Transplant Patients

NCT00997022 | Completed Phase 1 DMC

• 1 other identifier: AAAD3519
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

This Phase I study of sorafenib in high risk hepatocellular cancer patients after liver transplantation will study 24 subjects for about 5 years. Each subject will receive sorafenib for 6 months. Safety and effectiveness on the post transplant, high risk HCC patients will be studied.

Conditions

Hepatocellular Cancer

Keywords

HCC; High-risk Hepatocellular Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of daily sorafenib

  Every two weeks throughout six cycles

Secondary Outcomes (2)

• Duration of disease free survival

  Every three months for 2 years

• Duration of progression free survival

  Every three months for 2 years

Study Arms (1)

Sorafenib

EXPERIMENTAL

Daily sorafenib taken orally

Drug: Sorafenib

Interventions

Sorafenib DRUG

Dose escalation: Dose level 1: 200mg of sorafenib daily Dose level 2: 200mg of sorafenib BID (twice daily) Dose level 3: 200mg QAM (taken every morning) and 400mg QPM (taken every evening) Dose level 4: 400mg BID (twice daily)

Also known as: Nexavar

Sorafenib

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old
• ECOG Performance Status 0-2
• Post liver transplant and have explants with histologically confirmed hepatocellular carcinoma.
• No evidence of HCC disease at study entry by imaging
• Eligible to start 4 weeks post transplant (29 days post transplant) as long as they are on stable doses of immunosuppressants.
• "High risk" for recurrence after transplantation
• Received prior surgical resection, chemoembolization or other local therapy prior to transplant.
• Have Child-Pugh Class A or compensated Child-Pugh Class B liver dysfunction at the start of therapy
• Have adequate bone marrow, liver and renal function as assessed by the following:
• Hemoglobin ≥ 8.0 g/dl
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
• Platelet count ≥ 75,000/mm3
• Total bilirubin ≤ 1.5 times ULN
• ALT and AST ≤ 5 x ULN
• Creatinine ≤ 1.5 times ULN

You may not qualify if:

• Cardiac disease: Congestive heart failure \> class II NYHA.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension, defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• Active clinically serious infection \> CTCAE Grade 2.
• Thromboembolic events such as a cerebrovascular accident (including transient ischemic attacks) within the past 6 months.
• Any hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture within 4 weeks of first dose of study drug.
• Evidence or history of bleeding diathesis or coagulopathy within 4 weeks of first dose of study drug.
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• Use of St. John's Wort or rifampin within 4 weeks of first dose of study drug.
• Known or suspected allergy to sorafenib or any agent given in the course of this trial.
• Any condition that impairs patient's ability to swallow whole pills.
• Patients who are pregnant or breastfeeding. Breastfeeding should be discontinued if the patient is to be treated.
• Prior malignancy treated during the prior 5-years (other than localized non-melanoma carcinoma of the skin).
• Any condition or social situation that may limit patient's compliance with the study regimen

Sponsors & Collaborators

• Columbia University: lead
• Bayer: collaborator
• Amgen: collaborator

Study Sites (3)

University of Southern California

Los Angeles, California, 90089, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Columbia University Medical Center

New York, New York, 10032, 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

Study Officials

• Abby Siegel, MD, MS

  Columbia University

  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: October 14, 2009
• First Posted: October 16, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

US (3)