ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pancreatic Cancer

In brief

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. Funded by: FDA OOPD (Grant #FD-R-006817-01), H2020 EIC Accelerator (Grant #954825) and Ability Pharmaceuticals SL.

Key facts

Study ID: NCT04431258
Run by: Ability Pharmaceuticals SL
People needed: 150
Starts: 2021-05-06
Expected to finish: 2024-01-10
Last updated by the study team: 2024-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas.
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 0-1.
Age, older than 18 years old
Adequate hematologic function, measured as:
absolute neutrophil count ≥ 1.5x109/L
platelet count ≥ 100x109/L without transfusion support
hemoglobin ≥ 10 g/dL
Total bilirubin ≤ 1.5 x ULN
Albumin ≥ 3.3 g/dL
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 m2
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.
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.
Willing and able to provide informed consent
Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol.

You may not qualify if…

Patients with any histology other than carcinoma, adenocarcinoma or ductal adenocarcinoma (such as squamous cell, acinar cell, medullary, colloid, neuroendocrine, etc)
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.
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.
Patients unable to provide informed consent like those under administrative or legal supervision

Where it is running

Cedars Sinai — Los Angeles, California, United States
University of Kansas Cancer Center — Westwood, Kansas, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University of Cincinnati — Cincinnati, Ohio, United States
CGFL Dijon — Dijon, France
Institute Paoli-Calmettes — Marseille, France
Institut Gustave Roussy — Villejuif, France
Rabam MC — Haifa, Israel
Shaare Zedek MC — Jerusalem, Israel
Sheba MC — Ramat Gan, Israel
ICO Badalona — Badalona, Barcelona, Spain
Centro Oncológico de Galicia — A Coruña, Galicia, Spain
Hospital General Universitario Dr. Balmis — Alicante, Spain
Hospital Quiron Salud — Barcelona, Spain
Vall d'Hebron University Hospital — Barcelona, Spain
ICO Girona — Girona, Spain
Hospital Universitari Arnau de Vilanova — Lleida, Spain
Hospital Gregorio Marañón — Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital General Universitario Morales Meseguer — Murcia, Spain
Hospital Universitario Virgen del Rocío — Seville, Spain
Hospital Universitario de Toledo — Toledo, Spain
Hospital Universitario de Valencia — Valencia, Spain
Hospital Universitario Miguel Servet — Zaragoza, Spain

Full record on ClinicalTrials.gov

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