A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

Launched by HOFFMANN-LA ROCHE · May 16, 2023

Keywords

ClinConnect Summary

This clinical trial is designed for patients with cancer who have previously participated in a study sponsored by Genentech or Roche. The main goal of this trial is to provide ongoing treatment with specific investigational medicines or a combination of these medicines for those who are still benefiting from their current therapy but cannot access it locally. If you are eligible, you will continue receiving treatment that has shown to be helpful for your cancer, ensuring that you maintain your care without interruption.

To qualify for this trial, you need to have been receiving treatment in a previous study and still be benefiting from it at the time of this rollover. You should also be able to start the new treatment within a week after the previous study ended. However, if you have had to stop treatment for any reason in the past study, or if the treatment is now available to you outside of the study, you may not be eligible. Participants can expect to receive the same investigational treatments they were on previously, and the study is currently recruiting individuals between the ages of 65 and 74. This study offers a chance to continue important cancer treatment in a supportive environment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eligible for continuing Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol OR
• • Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
• • First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
• • Continue to benefit from the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator
• • Ability to comply with the extension study protocol, per Investigator's judgement
• Exclusion Criteria:
• • Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
• • Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant
• • Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
• • Permanent discontinuation of all study treatment(s) or comparator agent(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
• • Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
• • Concurrent participation in any therapeutic clinical trial (other than the parent study)