Clinical trial · Interventional
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 2, Open-label Study of Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
NCT03397394CI-TRIAL-00067031ATLASterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Efficacy did not meet the continuance criteria and DMC recommended to stop enrollment.
Summary
Brief summary (as posted)
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Urothelial Carcinoma | Urothelial Carcinoma | CURATED_BROADER | 0.78 |
| Muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
| Renal Pelvis Carcinoma | Renal Pelvis Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ureter Carcinoma | Ureter Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Urethra Carcinoma | Urethral Carcinoma | ALIAS | 0.90 |
| Urinary Bladder Carcinoma | Bladder Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rucaparib | Drug | Rucaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rucaparib
- description
- Oral rucaparib (monotherapy)
- interventionNames
- Drug: Rucaparib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) Per RECIST Version 1.1
- timeFrame
- Time from first dose to date of progression, up to approximately 19 months
- description
- 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 outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGrivas P, Loriot Y, Morales-Barrera R, Teo MY, Zakharia Y, Feyerabend S, Vogelzang NJ, Grande E, Adra N, Alva A, Necchi A, Rodriguez-Vida A, Gupta S, Josephs DH, Srinivas S, Wride K, Thomas D, Simmons A, Loehr A, Dusek RL, Nepert D, Chowdhury S. Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS). BMC Cancer. 2021 May 24;21(1):593. doi: 10.1186/s12885-021-08085-z. PMID 34030643