臨床研究等提出・公開システム

AN OPEN-LABEL, MULTICENTER EXTENSION STUDY IN PATIENTS PREVIOSULY ENROLLED IN A GENENTECH AND/OR F.HOFFMANN-LA ROCHE LTD SPONSORED STUDY

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

Timothy Eisen

Hoffmann-La Roche

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Recruiting

Aug. 29, 2023

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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)

Both

Cancer

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.

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

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

+81-45-520-2222

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Belgium/France/Poland/UK/Costa Rica/Mexico/Russia/Thailand/Korea/Taiwan