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

Part of paid clinical trials in Los Angeles, California.

Sponsor
pharmaand GmbH
Study ID
NCT04171700
Phase
PHASE2
Status
Terminated

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).

Study Details

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.

Key Dates

Start date
Jan 16, 2020
Status verified
Sep 2023
Primary completion
Jun 8, 2022
Completion
Jul 15, 2022

Study Design

Enrollment
83 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rucaparib
    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.

Primary Outcome Measure

Best Overall Response Rate by Investigator [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]

Locations (19)

FacilityCityStateZIPSite coordinators
UCLA Medicine Hematology and OncologyLos AngelesCalifornia90024-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
Florida Cancer SpecialistsFort MyersFlorida33901-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicagoIllinois60611-
University of Iowa Hospital and ClinicsIowa CityIowa52242-
Beth Israel Deaconess Medical Cancer Surgical PavilionBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Columbia University Irving Medical CenterNew YorkNew York10032-
New York Cancer and Blood SpecialistsPort Jefferson StationNew York11776-
New York Cancer And Blood SpecialistsThe BronxNew York10469-
Ohio State UniversityColumbusOhio43210-
Stephenson Cancer Center - The University of OklahomaOklahoma CityOklahoma73104-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
SCRI/Tennessee Oncology - ChattanoogaChattanoogaTennessee37404-
Tennessee OncologyNashvilleTennessee37203-
Seattle Cancer Care Alliance/University of WashingtonSeattleWashington98109-

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