Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Phase 2

Terminated

• Conditions: Bladder Cancer; Metastatic Urothelial Carcinoma; Ureter Carcinoma; Muscle Invasive Bladder Cancer; Urothelial Carcinoma; Urinary Bladder Carcinoma; Renal Pelvis Carcinoma; Urethra Carcinoma
• Interventions: Drug: Rucaparib

• Registration Number: NCT03397394
• Lead Sponsor: pharmaand GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-12
• Study Start: 2018-06-01
• Primary Completion: 2019-12-12
• Study Completion: 2020-01-15
• Results First Submitted: 2020-07-31
• Results First Submitted QC: 2020-10-16
• Results First Posted: 2020-10-19
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-07
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: TERMINATED
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rucaparib	Rucaparib	Oral rucaparib (monotherapy)

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) Per RECIST Version 1.1	Time from first dose to date of progression, up to approximately 19 months	ORR is defined as the proportion of patients with a confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR), is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	The total study time for reporting of deaths was approximately 19 months.	Overall survival (OS) was defined as time from the date of first dose of rucaparib to the date of death due to any cause. Patients without a known date of death were to be censored on the date the patient was last known to be alive. A Kaplan-Meier analysis of OS was planned, however, due to early study termination and limited duration of OS follow-up, a descriptive summary of total deaths are presented. This includes deaths recorded on study (from first dose of study drug until 28 days after last dose of study drug), and deaths recorded in long-term follow-up (from last dose +28 days until death, loss to follow-up, withdrawal of consent, or study closure).
Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator	Cycle 1 Day 1 to End of Treatment, up to approximately 10 months	PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first.
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations	From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months	Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.

Trial Locations

Locations (64)

Pinnacle Oncology, Honor Health; 🇺🇸 Scottsdale, Arizona, United States

University of California San Diego (UCSD), Moores Cancer Center; 🇺🇸 La Jolla, California, United States

University of California, Los Angeles (UCLA); 🇺🇸 Los Angeles, California, United States

Universityof California, Irvine; 🇺🇸 Orange, California, United States

Saint John's Health Center - John Wayne Cancer Institute (JWCI); 🇺🇸 Santa Monica, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Hartford Health Care Cancer Institute; 🇺🇸 Hartford, Connecticut, United States

Eastern Connecticut Hematology & Oncology Associates (ECHO); 🇺🇸 Norwich, Connecticut, United States

Medstar Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Miami Cancer Institute, Baptist Health South Florida; 🇺🇸 Miami, Florida, United States

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