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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002093-30 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated Interferon Alfa-2a | Drug | Participants will maintain the same dose they were receiving in the parent protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Tumor Response | 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. | Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sofia | 1757 | Bulgaria | ||||
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A total of 9 participants were recruited in the study: 8 participants from study NO16006 (NCT02736721) and 1 participant from study NO16007 (NCT number not available).
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| ID | Title | Description |
|---|---|---|
| FG000 | Interferon Alfa-2A in Cancer Participants | Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Recombinant Interferon Alfa 2a | Drug | Participants will maintain the same dose they were receiving in the parent protocol. |
|
|
| Halifax |
| Nova Scotia |
| B3H 2Y9 |
| Canada |
| Lucknow | 226 014 | India |
| Moscow | 125167 | Russia |
| Moscow | 129110 | Russia |
| Košice | 040 66 | Slovakia |
| Durban | 4091 | South Africa |
| Valencia | 46009 | Spain |
| COMPLETED |
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| NOT COMPLETED |
|
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All participants who were recruited in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Interferon Alfa-2A in Cancer Participants | Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who were recruited in the study. | Posted | Number | participants | Baseline up to approximately 3 years |
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|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Overall Tumor Response | 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. | All participants who were recruited in the study. | Posted | Number | participants | Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years) |
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|
Baseline up to approximately 3 years
All participants who were recruited in the study. Only SAEs were planned to be monitored during this extension study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interferon Alfa-2A in Cancer Participants | Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years). | 1 | 9 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung Infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D000077190 | Interferon alpha-2 |
| ID | Term |
|---|---|
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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