SODIUM 2-HYDROXYLINOLEATE for Metastatic pancreatic ductal adenocarcinoma

Inclusion criteria

• {"criterion_text":"- Histologically or cytologically confirmed carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas.\n- AST (SGOT) and ALT (SGPT) ≤ 2.5 times x upper limit of normal (≤ 5 times the ULN in patients with evidence of liver metastases).\n- Alkaline phosphatase ≤ 2.5 times ULN (≤5 times the ULN in patients with evidence of liver metastases).\n- Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2.\n- 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.\n- 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.\n- 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.\n- Willing and able to provide informed consent.\n- Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol.\n- Confirmed metastatic disease.\n- 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.\n- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n- Age, older than 18 years old.\n- 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.\n- 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.\n- Total bilirubin ≤ 1.5 x ULN.\n- Albumin ≥ 3.3 g/dL."}

Exclusion criteria

• {"criterion_text":"- Patients with any histology other than carcinoma, adenocarcinoma or ductal adenocarcinoma (such as squamous cell, acinar cell, medullary, colloid, neuroendocrine, etc).\n- 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.\n- Patient has active Hepatitis B or C, human immunodeficiency virus (HIV) or Covid-19 infection with non-controlled disease according to the treating physician.\n- For France. Patients with complete absence of dihydropyrimidine dehydrogenase (DPD), defined as blood uracil level ≥150 ng/ml.\n- Patients unable to provide informed consent like those under administrative or legal supervision.\n- Patients has only locally advanced disease, resectable or borderline resectable.\n- The patient has received chemotherapy as adjuvant therapy for locally advanced disease, resectable or borderline resectable.\n- Patient has received previous abdominal radiotherapy, (with the exception of analgesic radiotherapy that was not performed on target lesions).\n- Patients previously treated with an inhibitor of the PI3K/Akt/mTOR pathway by a systemic route.\n- History of chronic diarrhea or inflammatory disease of the colon or rectum, or occlusion or sub-occlusion not resolved under symptomatic treatment.\n- Patient is pregnant or in lactation period. High sensitivity pregnancy test (urine or serum) to be performed within 7 days before study treatment starts.\n- 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.\n- 12-lead ECG with clinically relevant abnormality or showing a QTcF >450 ms, PR >210 ms, or QRS >120 ms at screening."}

Primary endpoints

• {"endpoint_text":"- Phase I: Recommended Phase II Dose (RP2D) of ABTL0812 in combination with FOLFIRINOX","definition_or_measurement_approach":"Determination of RP2D based on Phase I safety and tolerability evaluation of ABTL0812 plus FOLFIRINOX."}
• {"endpoint_text":"- Phase II: PFS using RECIST v1.1 by central review","definition_or_measurement_approach":"Progression-free survival assessed per RECIST v1.1 by central radiological review."}

Secondary endpoints

• {"endpoint_text":"- Phase I: PFS using RECIST v1.1 by investigator analysis","definition_or_measurement_approach":"Progression-free survival per RECIST v1.1 assessed by investigator."}
• {"endpoint_text":"- Phase I: Objective response rate (ORR)","definition_or_measurement_approach":"Objective response rate per RECIST criteria (not further specified)."}
• {"endpoint_text":"- Phase I: PFS at 6 months","definition_or_measurement_approach":"Proportion progression-free at 6 months (per RECIST v1.1 by investigator analysis)."}
• {"endpoint_text":"- Phase I: Pharmacokinetic analysis of plasma samples","definition_or_measurement_approach":"Pharmacokinetic analysis of plasma samples (methods not detailed)."}
• {"endpoint_text":"- Phase I: Analysis of TRIB3 and CHOP in blood samples. Additional biomarkers might be included","definition_or_measurement_approach":"Pharmacodynamic biomarker analysis of TRIB3 and CHOP in blood; additional biomarkers possible (methods not specified)."}
• {"endpoint_text":"- Phase II: PFS using RECIST v1.1 by investigator analysis","definition_or_measurement_approach":"Progression-free survival per RECIST v1.1 assessed by investigator."}
• {"endpoint_text":"- Phase II: Objective response rate (ORR)","definition_or_measurement_approach":"Objective response rate per RECIST criteria (methods not further specified)."}
• {"endpoint_text":"- Phase II: PFS at 6 months","definition_or_measurement_approach":"Proportion progression-free at 6 months (per RECIST v1.1)."}
• {"endpoint_text":"- Phase II: Time to second objective disease progression (PFS2)","definition_or_measurement_approach":"Time to second objective disease progression (definition not further specified)."}
• {"endpoint_text":"- Phase II: Time to response (TTR)","definition_or_measurement_approach":"Time from randomization to first documented response (definition not further specified)."}
• {"endpoint_text":"- Phase II: Duration of response (DOR)","definition_or_measurement_approach":"Duration of response as per standard definitions (not further specified)."}
• {"endpoint_text":"- Phase II: Overall survival (OS)","definition_or_measurement_approach":"Overall survival (time from randomization to death from any cause)."}
• {"endpoint_text":"- Phase II: OS at 1 year","definition_or_measurement_approach":"Overall survival rate at 1 year (method not further specified)."}
• {"endpoint_text":"- Phase II: Disease control rate (DCR) at 16 weeks by central review and investigator analysis","definition_or_measurement_approach":"Disease control rate at 16 weeks assessed by central review and investigator (per RECIST v1.1)."}
• {"endpoint_text":"- Phase II: Time to first subsequent therapy or death (TFST)","definition_or_measurement_approach":"Time to first subsequent anti-cancer therapy or death (definition not further specified)."}
• {"endpoint_text":"- Phase II: Adverse Events (AE) physical examination, vital signs and laboratory findings according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0","definition_or_measurement_approach":"Safety assessed by AEs, physical exam, vital signs and labs using CTCAE v5.0."}
• {"endpoint_text":"- Phase II: Pharmacokinetic analysis of plasma samples after capsules and oral solution","definition_or_measurement_approach":"PK analysis of plasma after different formulations (methods not specified)."}
• {"endpoint_text":"- Phase II: Analysis of TRIB3 and CHOP in blood samples. Additional biomarkers might be included","definition_or_measurement_approach":"Analysis of TRIB3 and CHOP in blood; additional biomarkers possible (methods not specified)."}
• {"endpoint_text":"- Phase II: Questionnaires QLQ-C30 and QLQ-PAN26 from EORTC","definition_or_measurement_approach":"Quality-of-life assessed using EORTC QLQ-C30 and QLQ-PAN26 questionnaires."}
• {"endpoint_text":"- Phase II: Analysis of DNA mutations and gene expression in solid and liquid biopsies (plasma)","definition_or_measurement_approach":"Analysis of DNA mutations and gene expression in tumor tissue and plasma (methods not specified)."}
• {"endpoint_text":"- Phase II: Analysis of carbohydrate antigen (CA 19-9) in blood. Additional biomarkers might be included","definition_or_measurement_approach":"CA 19-9 blood level analysis; additional biomarkers possible (methods not specified)."}

France

Earliest CTIS Part Ii Submission Date

23-10-2024

Latest Decision Or Authorization Date

05-11-2024

Processing Time Days

13

Number Of Sites

3

Number Of Participants

15

Spain

Earliest CTIS Part Ii Submission Date

23-10-2024

Latest Decision Or Authorization Date

05-09-2025

Processing Time Days

317

Number Of Sites

14

Number Of Participants

83

Primary sponsor

Full Name

Ability Pharmaceuticals S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain