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NCT04171700 · REGISTRY CONDITION SEARCH

A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes

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
2023-10-02

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.

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

Best Overall Response Rate by Investigator

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outcome · POSTED

Overall Response Rate by Independent Radiology Review

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outcome · POSTED

Duration of Response

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outcome · POSTED

Disease Control Rate

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Number of Participants Experiencing Treatment-emergent Adverse Events

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outcome · POSTED

Steady State Minimum Concentration [Cmin]

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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
Key Inclusion Criteria: * Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive disease * Measurable disease per RECIST v1.1 or modified RECIST v1.1 and PCWG3 (for prostate cancer) * Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: Breast cancer patients that are HER2 negative and have germline BRCA1 or BRCA2 mutations AND patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutations are ineligible for this trial. * At least one prior line of therapy extending overall survival or standard of care therapy for advanced disease. Note: Some tumor types have specific inclusion/exclusion criteria for previous treatments. * ECOG 0 or 1 * Tumor tissue available for genomic analysis, or must be willing to have a biopsy if no archival tumor tissue available * Adequate organ function * Life expectancy of 4 months Key Exclusion Criteria: * Active central nervous system brain metastases, leptomeningeal disease or primary tumor of CNS origin * Active second malignancy (Exceptions: Successfully treated malignancy with no active disease for 1 year, surgically cured and/or low-risk tumors, or patients receiving ongoing anticancer hormonal therapy for a previously treated cancer) * Pre-existing gastrointestinal disorders/conditions interfering with ingestion/absorption of rucaparib * Prior treatment with a PARP inhibitor * More than 3 prior lines of chemotherapy in the locally advanced/metastatic setting * History of myelodysplastic syndrome or acute myeloid leukemia
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Eligible participants will be enrolled in either Cohort A or Cohort B. Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D. Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
    intervention Names
    1. Drug: Rucaparib
    label
    Rucaparib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Rucaparib
    description
    Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).
    name
    Rucaparib
    other Names
    1. Rubraca
    2. Rucaparib camsylate
    3. Rucaparib tablets
    4. CO-338
    5. PF 01367338
    6. AG 014447
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
83
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
    measure
    Best Overall Response Rate by Investigator
    time Frame
    From first dose of study drug until disease progression (up to approximately 2 years)
secondary Outcomes
  1. description
    Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
    measure
    Overall Response Rate by Independent Radiology Review
    time Frame
    From first dose of study drug until disease progression (up to approximately 2 years)
  2. description
    Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.
    measure
    Duration of Response
    time Frame
    From first dose of study drug until disease progression (up to approximately 2 years)
  3. description
    Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.
    measure
    Disease Control Rate
    time Frame
    From first dose of study drug until disease progression (up to approximately 2 years)
  4. description
    Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.
    measure
    Progression-free Survival
    time Frame
    From first dose of study drug until disease progression (up to approximately 2 years)
  5. description
    Measure of clinical benefit, defined as the duration from study enrollment to death.
    measure
    Overall Survival
    time Frame
    From first dose of study drug until disease progression (up to approximately 2 years)
  6. measure
    Number of Participants Experiencing Treatment-emergent Adverse Events
    time Frame
    From first dose of study drug until disease progression (up to approximately 2 years)
  7. description
    Rucaparib pharmacokinetics
    measure
    Steady State Minimum Concentration [Cmin]
    time Frame
    From first dose of study drug until disease progression (up to approximately 2 years)
Full study description
brief Summary
A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.
Source references
references
  1. citation
    Anbil S, Seewald NJ, Chiorean EG, Hussein M, Kasi PM, Laux DE, Schwartz GK, Shapiro GI, Lin KK, Craib M, Maloney L, McLachlan K, Tukachinsky H, Schrock AB, Wang S, Sokol ES, Decker B, Nathanson KL, Domchek SM, Reiss KA. LODESTAR: A Single-Arm Phase II Study of Rucaparib in Solid Tumors With Pathogenic Germline or Somatic Variants in Homologous Recombination Repair Genes. JCO Precis Oncol. 2025 Jul;9:e2500090. doi: 10.1200/PO-25-00090. Epub 2025 Jul 9.
    pmid
    40632975
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
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      primary nct id
      NCT04171700
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      payload
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      id
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT04171700
        start
        0
      offset unit
      unicode_code_points
      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
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    Preserved source evidence · Not medical advice