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

JRCT ID: jRCT2031230279

Registered date:04/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cancer
• Date of first enrollment: 29/08/2023
• Target sample size: 2
• Countries of recruitment: Belgium,Japan,France,Japan,Poland,Japan,UK,Japan,Costa Rica,Japan,Mexico,Japan,Russia,Japan,Thailand,Japan,Korea,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): 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 study.

Outcome(s)

Primary Outcome

other
1.Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)

Secondary Outcome

safety
1.Number of Participants With Serious Adverse Events (SAEs)
2.Number of Participants With Adverse Events of Special Interest (AESIs)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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)

Related Information

• Primary Sponsor: Timothy Eisen
• Secondary ID(s): NCT05862285