Trial assessing the efficacy of suraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Leon Berard

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

completed 27 Jan 2026

Decision date (initial)

2026-01-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Astrazeneca

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the efficacy of saruparib in patients with HR-deficient advanced/metastatic PAAD

Secondary objectives 3

1. To further document the clinical activity of saruparib in patients with HR-deficient pancreatic cancer
2. To assess the safety and tolerability of SARUPARIB in pancreatic cancer patients
3. To assess the impact of saruparib on patient’ quality of life in the target population

Conditions and MedDRA coding

Pancreatic (PAAD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. I1. Male or female patient ≥18 years of age at time of informed consent form signature.
2. I2. Histologically proven advanced/metastatic PAAD not curable by surgery and/or definitive radiotherapy and not previously exposed to chemotherapy in advanced/metastatic setting. Note: Adjuvant gemcitabine is allowed provided 6 months have elapsed between completion of adjuvant chemotherapy and recurrence.
3. I3. Documented somatic or germline deleterious alteration resulting in the inactivation in at least one of the following genes BRCA1, BRCA2, PALB2, according to molecular screening performed on blood test for germ line (if already available) or tumor or liquid biopsies. Note 1: Patients with known germline BRCA/PALB2 mutations are eligible without prior molecular pre-screening. However, tumor tissue will be collected for these patients to confirm inactivation in the tumor. Note 2: For patients enrolled according to molecular screening based on liquid biopsy : a tumor sample must be sent to the Sponsor.
4. I4. Measurable disease at baseline according to RECIST V1.1. See notes in the protocol.
5. I5. Availability of 1) an archival representative formalin-fixed paraffin-embedded (FFPE) tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block OR 2) feasibility of a de novo tumor biopsy (either surgical, endoscopic or percutaneous).
6. I6. Eastern Cooperative Oncology Group Performance Status (PS ECOG) of 0 or 1 or 2 if stable for at least 2 weeks.
7. I7. Life expectancy > 16 weeks.
8. I8. Adequate hematologic and end-organ function, obtained within 7 days prior to C1D1
9. I9. Resting blood pressure systolic < 140 mmHg and diastolic <90 mmHg.
10. I10. 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 beginning signing the inform consent form (ICF) to 6 months after the final dose of study drug.
11. I11. Fertile men must agree to use an effective method of contraception from signing the ICF to 6 months after the last dose of study drug and to not donate sperm during the same period.
12. I12. 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.
13. I13. Patients must be covered by a medical insurance.

Exclusion criteria 14

1. E1. Patients with borderline resectable disease.
2. E12. Prior organ or bone marrow transplant.
3. E13. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results.
4. E14. Pregnant or lactating women.
5. E2. Patients not respecting the requirement for prior and concomitant treatment
6. E3. Inability to swallow capsules (bowel obstruction) or hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
7. E4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. See notes in the protocol.
8. E5. 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.
9. E6. Any known history or features suggestive of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
10. E7. History of persisting (> 2 weeks) severe pancytopenia due to any cause (eg, ANC < 0.5 x 109 /L or platelets < 50 x 109 /L).
11. E8. History of severe allergic or other hypersensitivity reactions to any component of saruparib.
12. E9. Patients with:  Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) unless their hepatitis B virus (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 protocol.  Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or  Human immunodeficiency virus (HIV) infection .
13. E10. Persistent toxicities related to prior treatment of grade > 1, excluding alopecia (all grades allowed), neuropathy grade 2 and lab value defined in inclusion criteria I8.
14. E11. Patients with Interstitial lung disease/pneumonitis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 3

1. • DCR after 16 weeks of treatment (DRC-16W) according to RECIST V1.1 • Best overall response Rate according to RECIST V1.1 • Duration of response (DoR), • Progression Free survival (PFS) • Overall survival (OS)
2. Incidence and severity of AEs (with severity determined according to NCI CTCAE v5.0) including AE related to vital signs and clinical laboratory test results.
3. Changes from baseline in Quality of Life using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Leon Berard

Sponsor organisation

Centre Leon Berard

Address

28 Rue Laennec

City

Lyon

Postcode

69008

Country

France

Scientific contact point

Organisation

Centre Leon Berard

Contact name

Dr Philippe Cassier

Public contact point

Organisation

Centre Leon Berard

Contact name

Clinical project manager

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications