Cancer
Conditions
Interventions
Ipatasertib: Ipatasertib will be administered at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent st
Sponsors
Timothy Eisen
Eligibility
Sex/Gender
All
Inclusion 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
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 or less 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, other 1.Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s) 2.Number and Severity of Participants With Selected Adverse Events Assessed as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| other Not applicable | — |
Countries
Belgium, Canada, China, Costa Rica, France, Greece, Japan, Korea, Mexico, Poland, Russia, Taiwan, Thailand, UK
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed