Clinical trialPhase 2Terminated
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes
- Outcome
- Stopped earlyThe study was terminated due to a change in development priorities. (Business decision)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 16 January 2020
- Expected end
- 15 July 2022
- Enrollment
- 83 participants
- Sites
- 19
- Primary outcomes
- Best Overall Response Rate by Investigator
- Sponsor
- Industry
- Results posted
- 2023-10-02
- Last update
- 2 October 2023
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Best Overall Response Rate by Investigator [From first dose of study drug until disease progression (up to approximately 2 years)]. Count Of Participants, Participants. Rucaparib Cohort A (n=61): 9; Rucaparib Cohort B (n=20): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Response Rate by Independent Radiology Review [From first dose of study drug until disease progression (up to approximately 2 years)].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response [From first dose of study drug until disease progression (up to approximately 2 years)]. Median, month (95% Confidence Interval). Rucaparib Cohort A (n=9): 4.1 (3.1 to NA) [Insufficient number of participants with events.]; Rucaparib Cohort B (n=2): 6.8 (2.6 to 10.9).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Control Rate [From first dose of study drug until disease progression (up to approximately 2 years)]. Number, percentage of participants (95% Confidence Interval). Rucaparib Cohort A (n=61): 36.1 (24.2 to 49.4); Rucaparib Cohort B (n=20): 25.0 (8.7 to 49.1).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival [From first dose of study drug until disease progression (up to approximately 2 years)]. Median, month (95% Confidence Interval). Rucaparib Cohort A (n=63): 3.7 (1.9 to 5.4); Rucaparib Cohort B (n=20): 3.6 (1.6 to 6.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [From first dose of study drug until disease progression (up to approximately 2 years)]. Median, month (95% Confidence Interval). Rucaparib Cohort A (n=63): 13.3 (10.6 to NA) [Insufficient number of participants with events.]; Rucaparib Cohort B (n=20): 8.0 (4.8 to 16.6).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Experiencing Treatment-emergent Adverse Events [From first dose of study drug until disease progression (up to approximately 2 years)]. Count Of Participants, Participants. Rucaparib Cohort A (n=63): 63; Rucaparib Cohort B (n=20): 20.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Steady State Minimum Concentration [Cmin] [From first dose of study drug until disease progression (up to approximately 2 years)].