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

  • Cancer
Trial Status:

Not yet recruiting

This trial runs in
Countries
Trial Identifier:

NCT05862285 2022-003414-36, 2023-504263-16-00 BX44273

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

      Hoffmann-La Roche Sponsor
      Phase 4 Phase
      NCT05862285 , BX44273 , 2022-003414-36, 2023-504263-16-00 Trial Identifier
      Ipatasertib Treatments
      Cancer Condition
      Official Title

      An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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 study treatment or comparator agent 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)

      For the latest version of this information please go to www.forpatients.roche.com

       

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