Spots Global Cancer Trial Database for ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study
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Trial Identification
Brief Title: ABTL0812 in Combination With FOLFIRINOX for First-line Treatment of Metastatic Pancreatic Study
Official Title: 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
Study ID: NCT04431258
Conditions
Study Description
Brief Summary: 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.
Detailed Description: Phase I: This is an open label Phase I to determine the RP2D of ABTL0812 in combination with FOLFIRINOX. All patients will receive ABTL0812 in combination with FOLFIRINOX. A dose de-escalation phase will be performed in which up to 3 different ABTL0812 dose levels will be tested in combination with FOLFIRINOX. ABTL0812 doses are: 1300 mg tid (starting dose), followed (if necessary) by 975 mg tid and 650 mg tid. Patient intra-escalation is not allowed. Phase II: This is a double blind, randomized, placebo-controlled Phase II multicenter study to evaluate ABTL0812 in combination with FOLFIRINOX for first-line treatment of metastatic pancreatic cancer. Patients will be randomized to one of two groups: arm A) receiving ABTL0812 in addition to FOLFIRINOX and arm B) receiving FOLFIRINOX plus placebo. Arm A) ABTL0812 + FOLFIRINOX Arm B) PLACEBO + FOLFIRINOX
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Sevilla, , Spain
Hospital Universitario de Toledo, Toledo, , Spain
Hospital Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Marc Cortal
Affiliation: Ability Pharmaceuticals SL
Role: STUDY_DIRECTOR
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