A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT03207347
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.

Study Details

This open-label, non-randomized study will investigate the use of niraparib in patients with tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.

Key Dates

Start date
Aug 13, 2018
Status verified
Sep 2023
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022

Study Design

Enrollment
37 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma.
  • Experimental: Cohort B
    This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610-
University of MiamiMiamiFlorida33136-
Orlando Health UF Health Cancer CenterOrlandoFlorida32806-

Find similar trials in Gainesville, FL

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By specialty
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By research site
University of Florida· Gainesville, FLUniversity of Miami· Miami, FLOrlando Health UF Health Cancer Center· Orlando, FL

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