A Phase 1/2 interventional study of ABTL0812 and Folfirinox in Pancreatic Cancer, sponsored by Ability Pharmaceuticals SL. Completed at 24 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Ability Pharmaceuticals SL · Phase 1/2, Interventional, and Treatment
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.
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
Ability Pharmaceuticals SL is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate hematologic function, measured as:
Exclusion criteria
FOLFIRINOX will be dosed according to the standard following regimen: * oxaliplatin 85 mg/m2, administered as 2-hour iv infusion * leucovorin 400 mg/m2, administered as 2-hour iv infusion * irinotecan 180 mg/m2, administered as 1.5-hour iv infusion * fluorouracil 2400 mg/m2, administered as 46-hour iv infusion every 2 weeks (=1 cycle) until disease progression or unacceptable toxicities. ABTL0812 will be administered daily at its RP2D. ABTL0812 will be administered as single agent during a run-in period of one week before starting the first cycle of FOLFIRINOX, then daily during chemotherapy cycles. Also, ABTL0812 will be maintained once chemotherapy is discontinued, if ABTL0812 is tolerated and if the patient is in response or stable disease.
Drug: ABTL0812 · Drug: Folfirinox
FOLFIRINOX will be dosed according to the standard following regimen: * oxaliplatin 85 mg/m2, administered as 2-hour iv infusion * leucovorin 400 mg/m2, administered as 2-hour iv infusion * irinotecan 180 mg/m2, administered as 1.5-hour iv infusion * fluorouracil 2400 mg/m2, administered as 46-hour iv infusion every 2 weeks (=1 cycle) until disease progression or unacceptable toxicities. Placebo will be administered at the same volume than ABTL0812 in arm A) FOLFIRINOX, then daily during chemotherapy cycles. Also, placebo will be maintained once chemotherapy is discontinued.
Drug: ABTL0812 · Drug: Placebo
ABTL0812 will be administered daily at its RP2D. ABTL0812 will be administered as single agent during a run-in period of one week before starting the first cycle of FOLFIRINOX, then daily during chemotherapy cycles. Also, ABTL0812 will be maintained once chemotherapy is discontinued, if ABTL0812 is tolerated and if the patient is in response or stable disease.
FOLFIRINOX will be dosed according to the standard following regimen: * oxaliplatin 85 mg/m2, administered as 2-hour iv infusion * leucovorin 400 mg/m2, administered as 2-hour iv infusion * irinotecan 180 mg/m2, administered as 1.5-hour iv infusion * fluorouracil 2400 mg/m2, administered as 46-hour iv infusionevery 2 weeks (=1 cycle) until disease progression or unacceptable toxicities.
Also known as: Chemotherapy
Placebo will be administered daily at the same regim as ABTL0812. Placebo will be administered as single agent during a run-in period of one week before starting the first cycle of FOLFIRINOX, then daily during chemotherapy cycles. Also, placebo will be maintained once chemotherapy is discontinued, if the patient is in response or stable disease.
Phase I - RP2D
Recommended Phase II Dose (RP2D) of ABTL0812 in combination with FOLFIRINOX
Time frame: 5 weeks
Phase II - PFS
PFS using RECIST v1.1 by central review
Time frame: 1 year
PFS
PFS using RECIST v1.1 by investigator analysis
Time frame: 1 year
ORR
Objective response rate
Time frame: 1 year
PFS 6 m
PFS
Time frame: 6 months
TTR
Time to response
Time frame: 1 year
DOR
Duration of response
Time frame: 1 year
OS
Overall survival
Time frame: 5 years
OS 1y
Overall survival
Time frame: 1 year
Adverse events
Number of participants with Adverse Events (AE). AEs classified according to CTCAE v5.0
Time frame: 1 year
PK - Cmax
Determination of peak plasma concentration
Time frame: 1 month
PK - AUC
Determinatoin of Area under the plasma concentration versus time curve
Time frame: 1 month
Quality of Life Questionnaire QLC-C30
Quality of life measured with questionnaires QLC-C30
Time frame: 1 year
Quality of Life Questionnaire QLQ-PAN26
Quality of life measured with questionnaires QLQ-PAN26
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Ability Pharmaceuticals SL