2024-516558-24-00撤回2 期
SARUPANC - A multicentric, single arm, phase II trial assessing the efficacy of suraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 700
- 试验地点
- 5
- 主要终点
- Objective response rate at Week 16 (ORR-16W) according to RECIST V1.1
研究概览
简要总结
To assess the efficacy of saruparib in patients with HR-deficient advanced/metastatic PAAD
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patient ≥18 years of age at time of informed consent form signature.
- •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.
- •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.
- •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.
- •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.
- •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.
- •Measurable disease at baseline according to RECIST V1.
- •See notes in the protocol.
- •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).
- •Eastern Cooperative Oncology Group Performance Status (PS ECOG) of 0 or 1 or 2 if stable for at least 2 weeks.
- •Life expectancy > 16 weeks.
- •Adequate hematologic and end-organ function, obtained within 7 days prior to C1D1
- •Resting blood pressure systolic < 140 mmHg and diastolic <90 mmHg.
排除标准
- •Patients with borderline resectable disease.
- •History of persisting (> 2 weeks) severe pancytopenia due to any cause (eg, ANC < 0.5 x 109 /L or platelets < 50 x 109 /L).
- •History of severe allergic or other hypersensitivity reactions to any component of saruparib.
- •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 .
- •Persistent toxicities related to prior treatment of grade > 1, excluding alopecia (all grades allowed), neuropathy grade 2 and lab value defined in inclusion criteria I
- •Patients with Interstitial lung disease/pneumonitis
- •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.
- •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 protocol.
- •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.
- •Any known history or features suggestive of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
结局指标
主要结局
Objective response rate at Week 16 (ORR-16W) according to RECIST V1.1
Objective response rate at Week 16 (ORR-16W) according to RECIST V1.1
次要结局
- • 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)
- 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.
- Changes from baseline in Quality of Life using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
研究者
Dr Philippe Cassier
Scientific
Centre Leon Berard
研究点 (5)
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