Trial Information

Summary: A Study to Provide Patients Who Have Responded to Treatment With PEGASYS (Peginterferon alfa-2a (40KD)) or Roferon-A (Interferon alfa-2a, Recombinant) in Prior Clinical Studies Continued Access to the Drug

Status: No longer recruiting

Protocol Number: NO17754

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of PEGASYS on tumor response in patients with chronic myelogenous leukemia, malignant melanoma, or renal cell carcinoma who have responded to treatment with PEGASYS or Roferon-A

Brief Summary: This extension study will give patients with chronic myelogenous leukaemia (CML), malignant melanoma (MM), or renal cell cancer (RCC) who responded to prior treatment with PEGASYS or Roferon-A the opportunity to continue with study drug. The safety of extended treatment will also be monitored. The anticipated time on study treatment is 2+ years and the target sample size is <100 individuals. Target sample size is 11.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Myelogenous Leukemia, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a (40KD)[PEGASYS]

Primary Outcome: 1. Efficacy: Tumor response

Key Secondary Outcomes: 1. Safety: Serious adverse events

Inclusion Criteria:

  • patients must have completed one of the prior studies with PEGASYS or Roferon-A and responded to treatment;
  • patients with CML must have a confirmed cytogenetic complete response within 2 months of entering the extension study;
  • patients with MM or RCC must have tumor assessments verifying stable or better response within 2 months of entering the extension study.

Exclusion Criteria:

  • pregnant or lactating women;
  • fertile men, or women of childbearing potential, not using adequate contraceptive measures (unless surgically sterile).

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2004

Trial Registration Date: 07/26/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Halifax, NS, Canada, B3J 3G9
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 2, 2008 at 2:14:25 PM


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