Trial Information

Summary: A Study to Optimize the Dose of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Metastatic Malignant Melanoma

Status: Completed

Protocol Number: NO16007

Sponsor: Hoffmann-La Roche Inc

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label, dose finding study of the effect of subcutaneous administration of PEGASYS on tumor response in patients with metastatic malignant melanoma.

Brief Summary: This study will evaluate the safety and efficacy of different doses of PEGASYS in patients with metastatic malignant melanoma. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. Target sample size is 135.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Condition: Malignant Melanoma

Intervention Type: Drug

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

Primary Outcome: 1. Efficacy: Measurements of visible and palpable tumor, disease response

Key Secondary Outcomes: 1. Safety: AEs, laboratory tests results, vital signs

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 75 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 07/26/2005

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: July 7, 2008 at 2:31:27 PM