An Open Label, Multicenter Extension Study In Patients Previously Enrolled In A Genentech And/Or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Study Identifier:
BO40729
CT.gov Identifier:
NCT03768063
EudraCT Identifier:
2018-003352-20
EU Trial (CTIS) Number:
2023-506184-34-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

To evaluate extension study in patients previously enrolled in a genentech- and/or f. hoffmann-la roche ltd-sponsored atezolizumab study

To provide continued treatment with atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of roll-over from the parent study who do not have access to the study treatment locally

To evaluate the safety of atezolizumab single-drug therapy or atezolizumab combined with other drugs.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Atezolizumab Monotherapy
    • Read More
  • Drug: Active Comparator: Comparator Treatment
  • Drug: Intervention:
  • Drug: Drug: Rucaparib
  • Drug: Test Drug:
  • Drug: investigational material(s)
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Patients must meet the following criteria for study entry:
    • Signed extension study Informed Consent Form
    • Eligible for continuing atezolizumab-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
    • Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. 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 atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator
    • Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
    • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
    • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
    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 patient's country for the patient-specific disease and is accessible to the patient
    • Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study
    • Permanent discontinuation of atezolizumab 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). Exception: Participants who permanently discontinued atezolizumab from parent studies that permit participants to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study.
    • Ongoing serious adverse event(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
    • Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
    • Concurrent participation in any therapeutic clinical trial (other than the parent study)
    • Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated referenced safety information (RSI)

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer