Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Phase 1

• Conditions: ocally Advanced Unresectable or Metastatic Urothelial Carcinoma; MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10044412Term: Transitional cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004166-10-DE
• Lead Sponsor: Clovis Oncology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-17
• Study Completion: 2020-01-15
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Have histologically or cytologically confirmed locally advanced unresectable or metastatic transitional cell carcinoma of the urothelium (renal pelvis, ureter, urinary bladder or urethra)
• Received 1 or 2 prior treatment regimens for locally advanced unresectable or metastatic disease and c onfirmed radiologic disease progression during or following recent treatment. The principal investigator is
responsible for ensuring the patient has received standard of care treatment as appropriate in the country of enrollment, taking into account the patient’s current health status as well as how they responded to/tolerated prior treatment(s).
• Mandatory biopsy is required during screening
• Measurable disease per RECIST v1.1
• Adequate organ function
• ECOG 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

• Prior treatment with a PARP inhibitor
• Symptomatic and/or untreated CNS metastases
• Duodenal stent and/or any gastrointestinal disorder that may interfere with absorption of rucaparib

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified