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

Metastatic pancreatic ductal adenocarcinoma

Phase I: Recommended Phase II Dose (RP2D) of ABTL0812 in combination with FOLFIRINOX, Phase II: PFS using RECIST v1.1 by central review

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

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