PARPi-PANC - 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 - PARPi-PANC

Centre Léon Bérard0 个研究点目标入组 28 人开始时间: 2022年4月13日最近更新: 2023年9月26日

适应症

试验速览

暂无简介。

•I1. Male or female patient =18 years of age at time of informed consent form signature.
•I2. 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
•I3. Documented deleterious alteration resulting in the bi-allelic 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
•I4. Measurable disease at baseline according to RECIST V1.1 (See Section Appendix) See note in the full protocol
•I5. For patient with an unknown HR status, a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality/quantity control criteria: =30 % of tumor cells and a tumor surface area = 5mm2. For patients with known HR defect in the tumor, an archival tumor sample will be collected if available.
•… See the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•E1. Patients not respecting the requirement for prior and concomitant treatment...
•E2. Inability to swallow capsules (bowel obstruction) or hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
•E3. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. See notes in the full protocol.
•E4. 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.
•E5. Any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
•...See the protocol

发起方

Centre Léon Bérard