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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862285
Collaborator
(none)
60
Enrollment
1
Arm
119
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
May 1, 2033
Anticipated Study Completion Date :
May 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ipatasertib

Participants will continue to receive Ipatasertib monotherapy or in combination with other agent(s) or comparator agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.

Drug: Ipatasertib
Ipatasertib will be administered as a monotherapy or in combination with other agent(s) or comparator agent(s) at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.
Other Names:
  • RO5532961

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s) [Up to approximately 10 years]

    Secondary Outcome Measures

    1. Number of Participants With Serious Adverse Events (SAEs) [Up to approximately 10 years]

    2. Number of Participants With Adverse Events of Special Interest (AESIs) [Up to approximately 10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT05862285
    Other Study ID Numbers:
    • BX44273
    • 2022-003414-36
    • 2023-504263-16-00
    First Posted:
    May 17, 2023
    Last Update Posted:
    May 17, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Ipatasertib

    Study Results

    No Results Posted as of May 17, 2023