Continuation of treatment for cancer patients from previous studies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This extension study aims to provide ongoing treatment with Roche investigational medicinal products or comparator agents for cancer patients who were previously enrolled in Genentech or Roche-sponsored studies. Eligible participants will receive either monotherapy or combination therapy based on their prior treatment and current needs. The study is designed for those who are still benefiting from their treatment and do not have local access to these investigational therapies. The first dose in this extension will be administered within a week of the treatment interruption from the parent study.

Why it matters

Who can join: the full rules

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 all study treatment(s) or comparator agent(s) 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. Potential participants with an ongoing SAE that has not resolved to baseline level or Grade 1 may be enrolled at the investigator's discretion, provided the event is deemed clinically stable and the investigator documents that the potential clinical benefit outweighs the risk to the potential participant.
* Concurrent participation in any therapeutic clinical trial (other than the parent study)

Where it's running

• Princess Margaret Cancer Center
  Toronto, Ontario, Canada Recruiting
• Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
  Wuhan, Hubei, China Recruiting
• First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  XI 'an City, Shaanxi Province, Shaanxi, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Beijing Cancer Hospital
  Beijing, China Recruiting
• the First Hospital of Jilin University
  Changchun, China Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.