At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 enrolled
Drug / intervention
Niraparibdrug
Likely dose
Niraparib 300 mg orally once daily (28-day cycle)AI-extracted
Key inclusion· 8
- ✓Age ≥18 years
- ✓Histologically confirmed incurable cancer (uveal melanoma, mesothelioma, renal cell carcinoma clear cell subtype, or cholangiocarcinoma)
- ✓Known DDR pathway mutation (including BAP1, ATM, BRCA pathway genes, and others) confirmed by CLIA-certified NGS; VUS allowed
- ✓Prior treatment with standard systemic therapy (must have exhausted or declined all approved effective life-prolonging therapies)
Key exclusion· 11
- ✕Prior exposure to PARP inhibitors
- ✕Known BRCA1 or BRCA2 mutation
- ✕Pathologic diagnosis of prostate cancer (Cohort B only)
- ✕Active symptomatic brain or leptomeningeal metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of the PARP Inhibitor, Niraparib, in BAP1 and Other DNA Damage Response (DDR) Pathway Deficient Neoplasms (UF-STO-ETI-001)
In Brief
A Phase 2 clinical trial evaluating Niraparib for Mesothelioma and 3 related conditions. Completed, enrolled 37 participants across 3 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMesothelioma, Uveal Melanoma, Renal Cell Carcinoma, Cholangiocarcinoma
CountriesUnited States
CollaboratorsGlaxoSmithKline
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartAug 2018
Primary CompletionAug 2022
TodayJul 2026
First PostedJul 2, 2017
Enrollment StartAug 13, 2018
Primary CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9 years ago
Interventions
Niraparibdrug
Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.