Trial Information

Summary: A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.

Status: Recruiting

Protocol Number: ML21213

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A single arm, open label study of first line treatment with Tarceva plus Avastin on progression-free survival in patients with advanced or metastatic liver cancer

Brief Summary: This single arm study will evaluate the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients will be treated with Tarceva 150mg po daily plus Avastin 5mg/kg i.v. every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals. Target sample size is 49.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Liver Cancer

Intervention Type: Drug

Intervention Name: bevacizumab [Avastin]

Primary Outcome: 1. Progression-free survival Time frame: Week 16

Key Secondary Outcomes: 1. Overall response rate, disease control rate, time to tumor progression, progression-free survival, overall survival. Time frame: Event driven 2. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • advanced or metastatic liver cancer;
  • >=1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment.

Exclusion Criteria:

  • prior or concomitant systemic anti-cancer treatment for advanced disease;
  • patients at high risk of variceal bleeding;
  • clinically significant cardiovascular disease;
  • major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2008

Trial Registration Date: 01/21/2008

Date Last Updated: 09/19/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Tainan, Taiwan, 704
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: October 6, 2008 at 2:58:36 PM


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