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

NCT02829775 | Completed Phase 2 Results

• 2 other identifiers: NO177542004-002093-30
• Study Type: interventional
• Target: 9
• Locations: 7 countries
• Sites: 8

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).

Conditions

Chronic Myelogenous Leukemia; Malignant Melanoma; Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Serious Adverse Events (SAEs)

  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.

  Baseline up to approximately 3 years

Secondary Outcomes (1)

• 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)

Study Arms (1)

Interferon Alfa-2A in Cancer Participants

EXPERIMENTAL

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).

Drug: Pegylated Interferon Alfa-2a; Drug: Recombinant Interferon Alfa 2a

Interventions

Pegylated Interferon Alfa-2a DRUG

Participants will maintain the same dose they were receiving in the parent protocol.

Also known as: Pegasys

Interferon Alfa-2A in Cancer Participants

Recombinant Interferon Alfa 2a DRUG

Participants will maintain the same dose they were receiving in the parent protocol.

Also known as: Roferon-A

Interferon Alfa-2A in Cancer Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Unknown Facility

Sofia, 1757, Bulgaria

Location

Unknown Facility

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Unknown Facility

Lucknow, 226 014, India

Location

Unknown Facility

Moscow, 125167, Russia

Location

Unknown Facility

Moscow, 129110, Russia

Location

Unknown Facility

Košice, 040 66, Slovakia

Location

Unknown Facility

Durban, 4091, South Africa

Location

Unknown Facility

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Carcinoma, Renal Cell

Interventions

peginterferon alfa-2a; Interferon alpha-2

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 12, 2016
• Study Start: January 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 9, 2017
• Results First Posted: November 17, 2016

Record last verified: 2016-07

Locations

ES (1); ZA (1); RU (2); IN (1); BU (1); CA (1); SL (1)