Niraparib as First Line Therapy With Metastatic Homologous Repair-deficient Pancreatic Cancer

NCT05442749 | Terminated Phase 2 DMC

• 1 other identifier: ET21-169
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 4

Brief Summary

This trial is a single arm open-label, phase II aiming to assess the clinical activity of niraparib in chemotherapy-naïve biomarker-selected pancreatic cancer patients.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of niraparib in patients with HR-deficient pancreatic cancer

  Objective response rate at Week 16 (ORR-16W) according to RECIST V1.1

  16 weeks

Secondary Outcomes (6)

• Disease control rate (DCR)

  16 weeks

• Best overall response Rate

  At least 12 months following inclusion

• Duration of response (DoR)

  At least 12 months following inclusion

• Progression Free survival (PFS)

  At least 12 months following inclusion

• Overall survival (OS)

  At least 12 months following inclusion

Other Outcomes (1)

• PD biomarkers of response and resistance to niraparib

  At screening, cycle 3 day 1, cycle 5 day 1, cycle 7 day 1, (each cycle is 28 days) and at the end of study visit (within 30 days after last treatment administration)

Study Arms (1)

Niraparib

EXPERIMENTAL

Drug: Niraparib

Interventions

Niraparib DRUG

Eligible patients will receive niraparib once daily, per os, continuously until loss of clinical benefit, unacceptable toxicity, death, patient or physician decision to withdraw, or pregnancy, whichever occurs first. 300 mg/day, continuously for patients with TB \>1.5- 3 ULN and/or ASAT/ALAT ≤5ULN. Or 200mg/day initial dosing for patients with TB \>1.5 ULN and up to 3ULN and/or ASAT/ALAT \> 2.5 ULN and up to 5 ULN with increase to 300mg/day if 1) liver safety lab tests improve to Grade 1 according to NCI criteria (based on total bilirubin and AST/ALT) with bilirubin \< 1.5ULN) and 2) no grade \>1 related AE are reported.

Niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient ≥18 years of age at time of informed consent form signature.
• 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
• Documented deleterious alteration resulting in 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
• Measurable disease at baseline according to RECIST V1.1 (See Section Appendix) See note in the full protocol
• Avaibility of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology with the following quality/quantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2.
• Optional - Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permits core needle biopsy without unacceptable risk of a significant procedural complications, and suitable for retrieval of a minimum of 4 cores with a needle minimum diameter :16-gauge. See note in the full protocol.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (See Section Appendix)
• Life expectancy \> 16 weeks.
• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 7 days prior to C1D1:
• Parameters Laboratory Value
• Absolute neutrophil count ≥ 1.5 109/L
• Platelets ≥ 100 109/L
• Hemoglobin ≥ 9 g/dL (without transfusion within 7 d)
• Serum creatinine OR Creatinine clearance according to CKD-EPI ≥ 30 mL/min/1.73 m2 for patient with creatinine levels \> 1.5 ULN
• Serum total bilirubin :

You may not qualify if:

• Patients not respecting the requirement for prior and concomitant treatment
• Inability to swallow capsules (bowel obstruction) or hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. See notes in the full protocol
• Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (eg, 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.
• Any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
• History of severe allergic or other hypersensitivity reactions to any component of niraparib.
• Patients with:
• Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study. See note in the full protocol.
• Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or
• HIV infection
• Prior organ or bone marrow transplant.
• Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results.
• Pregnant or lactating women.

Sponsors & Collaborators

• Centre Leon Berard: lead
• GlaxoSmithKline: collaborator

Study Sites (4)

Centre Georges François Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 5, 2022
• Study Start: October 28, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (4)