Pancreatic Cancer Clinical Trial
Official title:
A Phase I/II Open Label Study to Assess the Efficacy and Safety of ABTL0812 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Metastatic Pancreatic Cancer at First Line Therapy
A phase I/II open label study to assess the efficacy and safety of ABTL0812 in combination with gemcitabine and nab-paclitaxel in patients with advanced metastatic pancreatic cancer at first line therapy and as maintenance therapy after chemotherapy
This is a phase I/II study with differentiated endpoints for each phase. For phase I, primary
endpoint will be focused on safety and for phase II, primary endpoint will be focused on
efficacy.
Phase I:
Primary • To assess safety and tolerability and to identify the maximum tolerated dose (MTD),
dose-limiting toxicities (DLT) and the Recommended Phase II Dose (RP2D) of ABTL0812 plus
gemcitabine + nab-paclitaxel at first line therapy.
Secondary
- To evaluate the efficacy of ABTL0812 plus gemcitabine + nab-paclitaxel and as
maintenance therapy after chemotherapy
- To evaluate the pharmacokinetics of ABTL0812 alone and in combination with gemcitabine +
nab-paclitaxel
- To evaluate biomarkers to monitor activity ABTL0812 in combination with gemcitabine +
nab-paclitaxel
Phase II:
Primary
• To evaluate progression-free survival at 6 months (PFS-6m) according to RECIST guidelines.
Secondary
- To evaluate PFS and PFS-12m
- To evaluate tumor response according to Response Evaluation Criteria in Solid Tumors
(RECIST) guidelines
- To evaluate overall survival (OS)
- To assess safety and tolerability of ABTL0812 plus gemcitabine + nab-paclitaxel
according to CTACE v4.03
- To evaluate the pharmacokinetics of ABTL0812 alone and in combination with gemcitabine +
nab-paclitaxel
- To evaluate the pharmacodynamics of ABTL0812 in blood alone and in combination with
gemcitabine + nab-paclitaxel
;
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