BridgeMD
Trial assessing the efficacy of suraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer
EU CTIS ID: 2024-516558-24-00
What this study is testing
To assess the efficacy of saruparib in patients with HR-deficient advanced/metastatic PAAD
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- I1. Male or female patient ≥18 years of age at time of informed consent form signature.
- 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.
- 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.
- 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.
- I13. Patients must be covered by a medical insurance.
- 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.
You likely can't join if
- E1. Patients with borderline resectable disease.
- 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).
- E8. History of severe allergic or other hypersensitivity reactions to any component of saruparib.
- 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 .
- 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.
- E11. Patients with Interstitial lung disease/pneumonitis
See the full eligibility criteria
Who can join
- I1. Male or female patient ≥18 years of age at time of informed consent form signature.
- 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.
- 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.
- 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.
- I13. Patients must be covered by a medical insurance.
- 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.
- 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.
- I4. Measurable disease at baseline according to RECIST V1.1. See notes in the protocol.
- 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).
- I6. Eastern Cooperative Oncology Group Performance Status (PS ECOG) of 0 or 1 or 2 if stable for at least 2 weeks.
- I7. Life expectancy > 16 weeks.
- I8. Adequate hematologic and end-organ function, obtained within 7 days prior to C1D1
- I9. Resting blood pressure systolic < 140 mmHg and diastolic <90 mmHg.
What rules you out
- E1. Patients with borderline resectable disease.
- 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).
- E8. History of severe allergic or other hypersensitivity reactions to any component of saruparib.
- 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 .
- 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.
- E11. Patients with Interstitial lung disease/pneumonitis
- E12. Prior organ or bone marrow transplant.
- E13. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results.
- E14. Pregnant or lactating women.
- E2. Patients not respecting the requirement for prior and concomitant treatment
- E3. Inability to swallow capsules (bowel obstruction) or hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- E4. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. See notes in the protocol.
- 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.
- E6. Any known history or features suggestive of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.