2024-515379-36-00招募中2 期
A Phase I open label followed by a Phase II randomized, controlled study to assess the efficacy and safety of ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer
Ability Pharmaceuticals S.A.17 个研究点 分布在 2 个国家目标入组 98 人开始时间: 2024年11月5日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 17
- 主要终点
- Phase I: Recommended Phase II Dose (RP2D) of ABTL0812 in combination with FOLFIRINOX
研究概览
简要总结
-
For Phase I: Safety of ABTL0812 plus FOLFIRINOX.
-
For Phase II: To determine the efficacy of ABTL0812 in combination with FOLFIRINOX vs. FOLFIRINOX plus placebo by progression free survival (PFS) according to central review.
研究设计
- 研究类型
- Interventional
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
- 否
入选标准
- •Histologically or cytologically confirmed carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas.
- •AST (SGOT) and ALT (SGPT) ≤ 2.5 times x upper limit of normal (≤ 5 times the ULN in patients with evidence of liver metastases).
- •Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases).
- •Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^
- •Only for Phase II patients. If available, a sample of tumor tissue or cytology (either archival or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided.
- •For Spain. Contraception: All premenopausal female patients must use contraception. Male patients and their female partners (if fertile), must use contraception as well. In both cases, contraception means two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.
- •For France. Contraception: All premenopausal female patients must use contraception. Male patients and their female partners (if fertile), must use contraception as well. Contraception means two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug, and female patient should extend contraception measures up to 9 months of last chemotherapy session with oxaliplatin.
- •Willing and able to provide informed consent.
- •Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol.
- •Confirmed metastatic disease.
- •Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 guidelines with at least one “target lesion” to be used to assess response. Tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Age, older than 18 years old.
- •For Spain. Adequate hematologic function, measured as: absolute neutrophil count ≥ 1.5x10^9/L, platelet count ≥ 100x10^9/L without transfusion support and hemoglobin ≥ 10 g/dL.
- •For France. Adequate hematologic function, measured as: absolute neutrophil count ≥ 2.0x10^9/L, platelet count ≥ 100x10^9/L without transfusion support and hemoglobin ≥ 10 g/dL.
- •Total bilirubin ≤ 1.5 x ULN.
- •Albumin ≥ 3.3 g/dL.
排除标准
- •Patients with any histology other than carcinoma, adenocarcinoma or ductal adenocarcinoma (such as squamous cell, acinar cell, medullary, colloid, neuroendocrine, etc).
- •Patients with any other medical conditions (such as psychiatric illness, cardiovascular disease, infectious diseases, abnormal physical examination or laboratory findings) that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
- •Patient has active Hepatitis B or C, human immunodeficiency virus (HIV) or Covid-19 infection with non-controlled disease according to the treating physician.
- •For France. Patients with complete absence of dihydropyrimidine dehydrogenase (DPD), defined as blood uracil level ≥150 ng/ml.
- •Patients unable to provide informed consent like those under administrative or legal supervision.
- •Patients has only locally advanced disease, resectable or borderline resectable.
- •The patient has received chemotherapy as adjuvant therapy for locally advanced disease, resectable or borderline resectable.
- •Patient has received previous abdominal radiotherapy, (with the exception of analgesic radiotherapy that was not performed on target lesions).
- •Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway by a systemic route.
- •History of chronic diarrhea or inflammatory disease of the colon or rectum, or occlusion or sub-occlusion not resolved under symptomatic treatment.
- •Patient is pregnant or in lactation period. High sensitivity pregnancy test (urine or serum) to be performed within 7 days before study treatment starts.
- •Patient had myocardial infarction within ≤ 6 months prior to study entry, LVEF <50%, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina pectoris, or unstable cardiac arrhythmia requiring medication.
- •12-lead ECG with clinically relevant abnormality or showing a QTcF >450 ms, PR >210 ms, or QRS >120 ms at screening.
结局指标
主要结局
Phase I: Recommended Phase II Dose (RP2D) of ABTL0812 in combination with FOLFIRINOX
Phase I: Recommended Phase II Dose (RP2D) of ABTL0812 in combination with FOLFIRINOX
Phase II: PFS using RECIST v1.1 by central review
Phase II: PFS using RECIST v1.1 by central review
次要结局
- Phase I: PFS using RECIST v1.1 by investigator analysis
- Phase I: Objective response rate (ORR)
- Phase I: PFS at 6 months
- Phase I: Pharmacokinetic analysis of plasma samples
- Phase I: Analysis of TRIB3 and CHOP in blood samples. Additional biomarkers might be included
- Phase II: PFS using RECIST v1.1 by investigator analysis
- Phase II: Objective response rate (ORR)
- Phase II: PFS at 6 months
- Phase II: Time to second objective disease progression (PFS2)
- Phase II: Time to response (TTR)
- Phase II: Duration of response (DOR)
- Phase II: Overall survival (OS)
- Phase II: OS at 1 year
- Phase II: Disease control rate (DCR) at 16 weeks by central review and investigator analysis
- Phase II: Time to first subsequent therapy or death (TFST)
- Phase II: Adverse Events (AE) physical examination, vital signs and laboratory findings according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Phase II: Pharmacokinetic analysis of plasma samples after capsules and oral solution
- Phase II: Analysis of TRIB3 and CHOP in blood samples. Additional biomarkers might be included
- Phase II: Questionnaires QLQ-C30 and QLQ-PAN26 from EORTC
- Phase II: Analysis of DNA mutations and gene expression in solid and liquid biopsies (plasma)
- Phase II: Analysis of carbohydrate antigen (CA 19-9) in blood. Additional biomarkers might be included
研究者
Gemma Fierro
Scientific
Ability Pharmaceuticals S.A.
研究点 (17)
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