Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
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:
- male or female patients, 18-75 years of age;
- confirmed metastatic melanoma;
- bidimensionally measurable disease.
Exclusion criteria:
- fertile men or women, unless surgically sterile or using adequate contraceptive methods, and pregnant or lactating women;
- patients who have received previous interferon therapy, chemotherapy or immunotherapy, investigational agents, or vaccines for stage IV melanoma.
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: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Canada
- Calgary, AB
- Edmonton, AB
- Montreal, QC
France
- Bordeaux
- Marseille
- Nantes
Germany
Italy
Netherlands
Spain
Switzerland
United Kingdom
United States
- San Diego , CA
- San Francisco, CA
- Vallejo, CA
- Denver, CO
- Miami, FL
- Orlando, FL
- Rochester, MN
- Columbia , MO
- St. Louis, MO
- Albuquerque, NM
- New York, NY
- Rochester, NY
- Pittsburgh, PA
- Providence, RI
- Memphis , TN
- Seattle, WA
