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A Randomized 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.
Full description
This is an open-label, randomized phase I/II multicenter study to evaluate ABTL0812 in combination with gemcitabine and nab-paclitaxel at first line therapy. Patients will be assigned to the following groups during the study conduct:
For GROUP A:
Phase I: A 3+3 de-escalation design followed by an expansion phase will be performed
Phase II:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients ≥18 years of age
Willing and able to provide informed consent
Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.
Patient has one or more metastatic tumors measurable by CT scan (or MRI, if patient is allergic to CT contrast media).
Patient has not received previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
Patient has not received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Adequate hematologic function, measured as:
Total bilirubin ≤ 1.5 x ULN
Albumin ≤ 1.5 x ULN AST (SGOT) ≤ 2.5 times x upper limit of normal (ULN) 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)
Serum creatinine ≤1.5 ULN
Have adequate tumor tissue available (either archival or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided, if available.
Life expectancy ≥ 12 weeks in the opinion of the investigator
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
Contraception: All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months' consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug. Male patients and their female partners, who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.
Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.03).
Exclusion criteria
Inclusion criteria:
Patients fulfilling the following criteria are eligible for participation in the study:
Patients ≥18 years of age
Willing and able to provide informed consent
Ability and willingness to comply with study visits, treatment, testing, and to comply with the protocol
Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded. Initial diagnosis of metastatic disease must have occurred ≤6 weeks prior to inclusion in the study.
Patient has one or more metastatic tumors measurable by CT scan (or MRI, if patient is allergic to CT contrast media).
Patient has not received previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-FU or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
Patient has not received cytotoxic doses of gemcitabine or any other chemotherapy in the adjuvant setting
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Adequate hematologic function, measured as:
Total bilirubin ≤ 1.5 x ULN
Albumin ≤ 1.5 x ULN AST (SGOT) ≤ 2.5 times x upper limit of normal (ULN) 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)
Serum creatinine ≤1.5 ULN
Have adequate tumor tissue available (either archival or new tumor biopsy) for biomarker analyses. The most recently collected tumor tissue sample should be provided, if available.
Life expectancy ≥ 12 weeks in the opinion of the investigator
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
Contraception: All female patients will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months' consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically. Female patients of childbearing potential must agree to use two forms of highly effective contraception methods during the study and for a period of 6 months following the last administration of the study drug. Male patients and their female partners, who are of childbearing potential and are not practicing total abstinence, must agree to use two forms of highly effective contraception during the study and for a period of 6 months following the last administration of the study drug.
Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to ≤ grade 1 (as defined by Common Terminology Criteria for Adverse Events version 4.03).
Exclusion criteria:
Patients who meet one of more of the following criteria are not eligible:
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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