Trial Outcomes & Findings for 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 (NCT NCT02829775)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

9 participants

Primary outcome timeframe

Baseline up to approximately 3 years

Results posted on

2017-01-09

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	9
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Death	1
Overall Study Withdrawal by Subject	3
Overall Study Disease remission	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interferon Alfa-2A in Cancer Participants n=9 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).
Age, Continuous	48.1 years STANDARD_DEVIATION 18.3 • n=5 Participants
Gender Female	2 Participants n=5 Participants
Gender Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 3 years

Population: All participants who were recruited in the study.

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.

Outcome measures

Outcome measures
Measure	Interferon Alfa-2A in Cancer Participants n=9 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).
Number of Participants With Serious Adverse Events (SAEs)	1 participants

SECONDARY outcome

Timeframe: Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)

Population: All participants who were recruited in the study.

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.

Outcome measures

Outcome measures
Measure	Interferon Alfa-2A in Cancer Participants n=9 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).
Number of Participants With Overall Tumor Response CR	9 participants
Number of Participants With Overall Tumor Response PR	0 participants

Adverse Events

Interferon Alfa-2A in Cancer Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Interferon Alfa-2A in Cancer Participants n=9 participants at risk 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).
Infections and infestations Lung Infection	11.1% 1/9 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER