Patients with metastatic homologous repair-deficient pancreatic cancer
Conditions
Interventions
Trade Name: ZEJULA
Pharmaceutical Form: Capsule
Sponsors
Centre Léon Bérard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Male or female patient =18 years of age at time of informed consent form signature. I2. Histologically proven advanced/metastatic PDAC not curable by surgery and/or definitive radiotherapy and not previously exposed to chemotherapy in advanced/metastatic setting. See Note in the full protocol I3. Documented deleterious alteration resulting in the bi-allelic inactivation in at least one of the following genes BARD1, BRCA1, BRCA2, BRIP1, FANCA, FANCD2, FANCL, MRE11, NBN, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L. See Notes in the full protocol I4. Measurable disease at baseline according to RECIST V1.1 (See Section Appendix) See note in the full protocol I5. For patient with an unknown HR status, a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality/quantity control criteria: =30 % of tumor cells and a tumor surface area = 5mm2. For patients with known HR defect in the tumor, an archival tumor sample will be collected if available. … See the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: E1. Patients not respecting the requirement for prior and concomitant treatment... E2. Inability to swallow capsules (bowel obstruction) or hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. E3. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. See notes in the full protocol. E4. Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for = 2 years. E5. Any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). ...See the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of niraparib in patients with HR-deficient pancreatic cancer.;Secondary Objective: - To further document the clinical activity of niraparib in patients with HR-deficient pancreatic cancer - To assess the safety and tolerability of niraparib in pancreatic cancer patients;Primary end point(s): Objective response rate ;Timepoint(s) of evaluation of this end point: After Week 16 (ORR-16W) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease control rate (DCR) Best overall response Rate according to RECIST V1.1 Duration of response (DoR), Progression Free survival (PFS) Overall survival (OS) ;Timepoint(s) of evaluation of this end point: After 16 weeks of treatment (DRC-16W) | — |
Countries
France
Contacts
Public ContactDRCI - Phases précoces
Centre Léon Bérard
Outcome results
None listed