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

Primary Purpose

Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ipatasertib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • AZ Groeninge
  • Clinica CIMCARecruiting
  • ICIMED Instituto de Investigación en Ciencias MédicasRecruiting
  • Yokohama City University Medical CenterRecruiting
  • Kanagawa Cancer Center
  • Health Pharma Professional Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ipatasertib

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With Adverse Events of Special Interest (AESIs)

Full Information

First Posted
May 1, 2023
Last Updated
October 11, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05862285
Brief Title
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
May 1, 2033 (Anticipated)
Study Completion Date
May 1, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ipatasertib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ipatasertib
Other Intervention Name(s)
RO5532961
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)
Time Frame
Up to approximately 10 years
Secondary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events (SAEs)
Time Frame
Up to approximately 10 years
Title
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame
Up to approximately 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BX44273 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Recruiting
Facility Name
ICIMED Instituto de Investigación en Ciencias Médicas
City
San José
ZIP/Postal Code
10108
Country
Costa Rica
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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