A Rollover Study for Patients Previously Enrolled in a Genentech and/or F.Hoffman-La Roche Sponsored Study
- Conditions
- This is an extension study designed to provide continued treatment for eligible patients with cancer who were previously enrolled and treated in a Genentech/Roche study (the parent study), and do not have access to the treatment locallyTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504263-16-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
1. 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 Rochesponsored study as per the parent study protocol, with no access to commercially available comparator agent, 2. First dose of study treatment in this extension study will be received within 7days of the treatment interruption window allowed by the parent study, 3. 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, 4. Negative urine pregnancy test within 24 hours to first dose administered on BX44273 study treatment in women of childbearing potential, 5. Ability to comply with the extension study protocol, per Investigator's judgement
1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study, 2. Study treatment or comparator agent is commercially marketed in the patient’s country for the patient-specific disease and is accessible to the patient, 3. 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, 4. 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), 5. Ongoing serious adverse event(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, 6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatmentrelated complications
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To provide continued treatment with Roche investigational medicinal product (IMP)-based therapy and/or comparator agent(s) for eligible patients with cancer still on study treatment at the time of roll-over from the parent study who do not have access to the study treatment locally;Secondary Objective: 1. Safety: The incidence, nature, severity of serious adverse events and adverse events of special interest;Primary end point(s): 1. Number of Participants with Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1. The incidence, nature, severity of serious adverse events and adverse events of special interest