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

Cancer Clinical Trial

— UmbrellaMAX  

Official title:

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862285
• Other study ID #: BX44273
• Secondary ID: 2022-003414-3620
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: March 1, 2033

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BX44273 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2033
• Est. primary completion date: March 1, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Belgium	AZ Groeninge	Kortrijk
Costa Rica	Clinica CIMCA	San José
Costa Rica	ICIMED Instituto de Investigación en Ciencias Médicas	San José
France	Institut de cancerologie du Gard	Nimes
Japan	Kanagawa Cancer Center	Kanagawa
Japan	Yokohama City University Medical Center	Kanagawa
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Mexico	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)
Mexico	Centro Medico Culiacan SA de CV; Consultorio Medico 303 B	Culiacan	Sinaloa
Mexico	Consultorio de Especialidad en Urologia Privado	Durango
Mexico	Medical Care & Research	Mérida	Yucatan
Poland	Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.	Warszawa
Russian Federation	Moscow City Oncology Hospital #62	Moscovskaya Oblast	Moskovskaja Oblast
Russian Federation	P.A. Herzen Oncological Inst. ; Oncology	Moscow	Moskovskaja Oblast
Russian Federation	Russian Scientific Center of Roentgenoradiology	Moscow	Moskovskaja Oblast
Taiwan	Taichung Veterans General Hospital; Division of Urology	Taichung
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Royal Marsden Hospital - Surrey	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  Costa Rica,  France,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)		Up to approximately 10 years
Secondary	Number of Participants With Serious Adverse Events (SAEs)		Up to approximately 10 years
Secondary	Number of Participants With Adverse Events of Special Interest (AESIs)		Up to approximately 10 years