Clinical Trials List
2023-09-01 - 2033-12-31
Phase III
Recruiting2
Terminated2
ICD-10D07.5
Carcinoma in situ of prostate
ICD-9233.4
Carcinoma in situ of prostate
AN OPEN-LABEL, MULTICENTER EXTENSION STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH AND/OR F. HOFFMANN-LA ROCHE LTD SPONSORED STUDY
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Trial Applicant
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Sponsor
ROCHE PRODUCTS LTD.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chuan-Shu Chen Division of Urology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Po-Jung Su Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 顏志傑 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳佳穎 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Abiraterone acetate
Active Ingredient
Abiraterone acetate
Dosage Form
Tablet
Dosage
250mg/tablet
Endpoints
Inclution 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 • Negative urine pregnancy test within 24 hours to first dose administered on BX44273 study treatment in women of childbearing potential
• For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agree to refrain from donating eggs .
• For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm.
Exclusion Criteria
• Study treatment or comparator agent is commercially marketed in the patient’s country for the patient-specific disease and is accessible to the patient
• 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 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
• 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 treatment-related complications
• Concurrent participation in any therapeutic clinical trial (other than the parent study)
• Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated Reference Safety Information (RSI).
The Estimated Number of Participants
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Taiwan
4 participants
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Global
60 participants
