Clinical Trial Protocol Registry

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 150.
Study phase:
II
Study type:
Interventional; Treatment; Non-randomized; Uncontrolled; Parallel; Safety/efficacy study
Conditions:
  • Malignant Melanoma
Intervention type:
Drug
Intervention name:
peginterferon alfa-2a [Pegasys]
Primary outcome:
  1. Efficacy: Measurements of visible and palpable tumor, disease response\n
Key secondary outcomes:
  1. Safety: AEs, laboratory tests results, vital signs\n\n
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
Anticipated start date:
January, 2000
Trial registration date:
21.12.2005
Date last updated:
02.06.2010
This trial was conducted at the following locations:
Austria
  • WIEN
Canada
  • CALGARY, AB
  • EDMONTON, AB
  • MONTREAL, QC
France
  • BORDEAUX
  • MARSEILLE
  • NANTES
Germany
  • KIEL
  • MANNHEIM
  • TÜBINGEN
Italy
  • MILANO
Netherlands
  • ROTTERDAM
Spain
  • MADRID
  • VALENCIA
Switzerland
  • ZÜRICH
U.S.A.
  • 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
United Kingdom
  • GLASGOW
  • NORTHWOOD

Link to trial result

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