A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies

Phase 2

Completed

• Conditions: Malignant Melanoma; Chronic Myelogenous Leukemia; Renal Cell Carcinoma
• Interventions: Drug: Pegylated Interferon Alfa-2a; Drug: Recombinant Interferon Alfa 2a

• Registration Number: NCT02829775
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open label extension study will give an opportunity to the participants that have responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant Melanoma (MM).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Results First Submitted: 2016-09-28
• Results First Submitted QC: 2016-09-28
• Results First Posted: 2016-11-17
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol
• CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study

Exclusion Criteria

• Pregnant or lactating women
• Refusal to use adequate contraceptive measures among men and women of childbearing potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interferon Alfa-2A in Cancer Participants	Recombinant Interferon Alfa 2a	Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurs first (up to approximately 3 years).
Interferon Alfa-2A in Cancer Participants	Pegylated Interferon Alfa-2a	Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurs first (up to approximately 3 years).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events (SAEs)	Baseline up to approximately 3 years	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Overall Tumor Response	Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)	Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form.