Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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 Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2004
Trial registration date: 07/26/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
Canada
Germany
India
Russian Federation
Slovakia
South Africa
Spain
