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NCT03397394 · REGISTRY CONDITION SEARCH

Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2023-06-09

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR) Per RECIST Version 1.1

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outcome · POSTED

Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator

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outcome · POSTED

Overall Survival

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outcome · POSTED

Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Oral rucaparib (monotherapy)
    intervention Names
    1. Drug: Rucaparib
    label
    Rucaparib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Rucaparib
    description
    Rucaparib will be administered daily.
    name
    Rucaparib
    other Names
    1. CO-338
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
97
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Objective Response Rate (ORR) Per RECIST Version 1.1
    time Frame
    Time from first dose to date of progression, up to approximately 19 months
secondary Outcomes
  1. description
    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.
    measure
    Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator
    time Frame
    Cycle 1 Day 1 to End of Treatment, up to approximately 10 months
  2. description
    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).
    measure
    Overall Survival
    time Frame
    The total study time for reporting of deaths was approximately 19 months.
  3. description
    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.
    measure
    Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
    time Frame
    From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
Full study description
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.
Source references
references
  1. citation
    Grivas 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
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-762e1b7e1f4d156ae8e5
      requested nct id
      NCT03397394
      primary nct id
      NCT03397394
      source kind
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      source record id
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      payload sha256
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      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-762e1b7e1f4d156ae8e5
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT03397394
        end
        11
        exact text
        NCT03397394
        start
        0
      offset unit
      unicode_code_points
      query cond
      Urethral Cancer
      query disease state id
      ds-urethral-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-urethral-cancer-000.json
      source file sha256
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      source json pointer
      /studies/32/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      e7479493072438ecfabb32b3027c6282f6d5ae0816f74a39342fd9df5b8fc6a5

    Preserved source evidence · Not medical advice