AzTrials
AzTrials

Metastatic Pancreatic CancerPhase 2PARPi-PANCNCT05442749

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

A Phase 2 study testing Niraparib in people with Metastatic Pancreatic Cancer, run by Centre Leon Berard at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Niraparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
4 sitesFrance
Study dates
28 Oct 2022to 30 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 22Show fewer
  • 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 :
  • 300mg initial dosing: ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) OR Direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN 200mg initial dosing: up to 3 ULN
  • -- ASAT and ALAT : 300mg initial dosing: ≤ 2.5 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration) 200mg initial dosing up to 5ULN
  • Resting blood pressure systolic < 140 mmHg and diastolic <90 mmHg.
  • Women patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy test within 3 days prior to C1D1, and agrees to use a highly effective contraception (See section appendix) beginning signing the ICF to 6 months after the final dose of study drug.
  • Fertile men must agree to use an effective method of contraception (See section appendix) during the study and for up to 3 months after the last dose of study drug and to not donate sperm during the same period.
  • Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.
  • Patients must be covered by a medical insurance.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Centre Georges François Leclerc

    Dijon, 21079

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble, 38043

  • Centre Léon Bérard

    Lyon, 69373

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

Other trials in France

About this study

Official title: A Multicentric, Single Arm, Phase II Trial Assessing the Efficacy of Niraparib as First Line Therapy for Patients With Metastatic Homologous Repair-deficient Pancreatic Cancer

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.

Read the detailed description

This trial is a single arm open-label, phase II aiming to assess the clinical activity (objective response rate at week16 according to RECIST V1.1) of niraparib in chemotherapy-naïve biomarker-selected pancreatic cancer patients.

HR alterations must be confirmed before study drug start: only patients with mutation and/or rearrangement leading to inactivation in at least one of the following genes BARD1, BRCA1, BRCA2, BRIP1, FANCA, FANCD2, FANCL, MRE11, NBN, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L are eligible.

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.

Being tested
Niraparib
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    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.

Study groups in NCT05442749
Study groupRoleWhat they receive
NiraparibExperimentalNot described
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of niraparib in patients with HR-deficient pancreatic cancer

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

    Measured: 16 weeks

Secondary outcomes (6)

  1. Disease control rate (DCR)

    After 16 weeks of treatment (DRC-16W) according to RECIST V1.1

    Measured: 16 weeks

  2. Best overall response Rate

    According to RECIST V1.1

    Measured: At least 12 months following inclusion

  3. Duration of response (DoR)

    Measured: At least 12 months following inclusion

  4. Progression Free survival (PFS)

    Measured: At least 12 months following inclusion

  5. Overall survival (OS)

    Measured: At least 12 months following inclusion

  6. Safety and tolerability of niraparib in pancreatic cancer patients

    incidence and severity of AEs (with severity determined according to NCI CTCAE v5.0)

    Measured: At least 12 months following inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start28 Oct 2022
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Why it stopped: Study not feasible, patient accrual rate too low.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05442749
Sponsor's protocol ID
ET21-169
Acronym
PARPi-PANC
Status last verified
Feb 2026
First submitted
23 Jun 2022
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Metastatic Pancreatic Cancer, run by Centre Leon Berard at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study not feasible, patient accrual rate too low.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of niraparib in patients with HR-deficient pancreatic cancer (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05442749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in