Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (ATLAS)

pharmaand

Status and phase: Terminated; Phase 2

Conditions: Ureter Carcinoma; Urethra Carcinoma; Bladder Cancer; Muscle Invasive Bladder Cancer; Urinary Bladder Carcinoma; Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Renal Pelvis Carcinoma

Treatments: Drug: Rucaparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03397394

CO-338-085

2017-004166-10 (EudraCT Number)

Details and patient eligibility

About

The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.

Enrollment: 97 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 advanced or metastatic disease
• Confirmed radiologic disease progression during or following recent treatment
• Mandatory biopsy is required during screening
• Measurable disease per RECIST v1.1
• Adequate organ function
• ECOG 0 or 1

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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97 participants in 1 patient group

Rucaparib

Experimental group

Description:

Oral rucaparib (monotherapy)

Treatment:

Drug: Rucaparib