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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: Ipatasertib

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BX44273 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Belgium
  • Kortrijk, Belgium, 8500
    • Active, not recruiting
    • Az Groeninge
• Costa Rica
  • San José, Costa Rica, 10103
    • Active, not recruiting
    • Clinica CIMCA
  • San José, Costa Rica, 10108
    • Active, not recruiting
    • ICIMED Instituto de Investigación en Ciencias Médicas
• France
  • Nimes, France, 30029
    • Active, not recruiting
    • Institut de Cancérologie du Gard
• Japan
  • Kanagawa, Japan, 241-8515
    • Active, not recruiting
    • Kanagawa cancer center
  • Kanagawa, Japan, 232-0024
    • Active, not recruiting
    • Yokohama City University Medical Center
• Korea, Republic of
  • Seongnam-si, Korea, Republic of, 463-707
    • Active, not recruiting
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Active, not recruiting
    • Asan Medical Center
• Mexico
  • Durango, Mexico, 34000
    • Active, not recruiting
    • Consultorio de Especialidad en Urologia Privado
  • Mexico CITY (federal District)
    • Cdmx, Mexico CITY (federal District), Mexico, 03100
      • Withdrawn
      • Health Pharma Professional Research
  • Sinaloa
    • Culiacan, Sinaloa, Mexico
      • Recruiting
      • Centro Medico Culiacan SA de CV; Consultorio Medico 303 B
  • Yucatan
    • Mérida, Yucatan, Mexico, 97070
      • Recruiting
      • Medical Care & Research
• Poland
  • Warszawa, Poland, 04-073
    • Withdrawn
    • Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.
• Russian Federation
  • Moskovskaja Oblast
    • Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
      • Recruiting
      • Moscow City Oncology Hospital #62
    • Moscow, Moskovskaja Oblast, Russian Federation, 125248
      • Recruiting
      • P.A. Herzen Oncological Inst. ; Oncology
    • Moscow, Moskovskaja Oblast, Russian Federation, 117997
      • Active, not recruiting
      • Russian Scientific Center of Roentgenoradiology
• Taiwan
  • Taichung, Taiwan, 407
    • Recruiting
    • Taichung Veterans General Hospital; Division of Urology
  • Taoyuan, Taiwan, 333
    • Active, not recruiting
    • Chang Gung Memorial Hospital - Linkou
• United Kingdom
  • Leicester, United Kingdom, LE1 5WW
    • Recruiting
    • Leicester Royal Infirmary
  • Surrey, United Kingdom, SM2 5PT
    • Recruiting
    • Royal Marsden Hospital - Surrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ipatasertib; Participants will continue to receive Ipatasertib monotherapy or in combination with other agent(s) or comparator agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.

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.; Other Names: RO5532961

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)	Up to approximately 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Serious Adverse Events (SAEs)	Up to approximately 10 years
Number of Participants With Adverse Events of Special Interest (AESIs)	Up to approximately 10 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Ipatasertib
• Other Study ID Numbers: BX44273; 2022-003414-36 (EudraCT Number); 2023-504263-16-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No