Study Evaluating Efficacy And Safety Of FFX Versus Combination Of CPI-613 With MFFX In Patients With Metastatic Adenocarcinoma Of The Pancreas

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-04-12	Results First Submitted 2022-11-09	Last Update Submitted that met QC Criteria 2022-12-08
First Submitted that Met QC Criteria 2018-04-19	Results First Submitted that Met QC Criteria 2022-12-08	Last Update Posted (ACTUAL) 2023-01-03
First Posted (ACTUAL) 2018-04-20	Results First Posted 2023-01-03	Last Verified 2021-09

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CPI-613, mFolfirinox CPI-613, mFolfirinox CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle. mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV in	DRUG: CPI 613, mFolfirinox CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port. mFolfirinox: given immediately after CPI-613 administration
ACTIVE_COMPARATOR: Folfirinox Folfirinox Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min	DRUG: CPI 613, mFolfirinox CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port. mFolfirinox: given immediately after CPI-613 administration DRUG: Folfirinox Folfirinox

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CPI-613, mFolfirinox

CPI-613, mFolfirinox CPI-613 at 500 mg/m2 IV infusion at a rate of 4mL/min via a central venous port on day 1 and 3 of a 14-day cycle. mFolfirinox (given immediately after CPI-613 administration): Oxaliplatin (Eloxatin) at 65 mg/m2 given as a 2 hr IV in

DRUG: CPI 613, mFolfirinox

CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port. mFolfirinox: given immediately after CPI-613 administration

ACTIVE_COMPARATOR: Folfirinox

Folfirinox Folfirinox: Oxaliplatin (Eloxatin) at 85 mg/m2 given as a 2 hr IV infusion, Folinic acid at 400 mg/m2 given as a 90 min (1.5hr) infusion immediately after Oxaliplatin, and concurrently with Irinotecan (irinotecan at 180mg/m2 given as a 90 min

DRUG: CPI 613, mFolfirinox

CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port. mFolfirinox: given immediately after CPI-613 administration

DRUG: Folfirinox

Folfirinox

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival (OS)	Defined as the duration from the date of randomization to the date of death from any cause	38 months

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival (PFS)	Defined as the duration from the date of randomization to the date of progressive disease or death from any cause. Progressive Disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.	38 months
Overall Response Rate (ORR)	Defined as the rate of Complete Response (CR) plus Partial Response (PR): Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of diameters of target lesions;	38 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Adequate hematologic values

Platelet count ≥100,000 cells/mm3 or ≥100 bil/L;
Absolute neutrophil count [ANC] ≥1,500 cells/mm3 or ≥1.5 bil/L;
Hemoglobin ≥9 g/dL or ≥90 g/L)
Adequate hepatic function

Aspartate aminotransferase [AST/SGOT] ≤3x upper normal limit [UNL] (≤5x UNL if liver metastases present)
Alanine aminotransferase [ALT/SGPT] ≤3x UNL (≤5x UNL if liver metastases present)
Bilirubin (≤1.5x UNL); bilirubin ≤ 2.5 x ULN for subjects with Gilbert's syndrome
Serum albumin > 3.0 g/dL
Adequate renal function serum creatinine clearance CLcr > 30 mL/min). (Cocroft-Gault Formula should be used for CrCl calculation)
Adequate coagulation function • International Normalized Ratio or INR must be <1.5 unless on therapeutic blood thinners) 11. No evidence of active infection and no serious infection within the past 30 days. 12. Mentally competent, ability to understand and willingness to sign the informed consent form.

Calcium Folinate is contraindicated in patients who have previously shown hypersensitivity to folinate or any of the excipients.
Calcium Folinate Injection is contraindicated in the treatment of pernicious anemia or other megaloblastic anemias where vitamin B12 is deficient. Its use can lead to an apparent response of the hematopoietic system, but neurological damage may occur or progress if already present.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take calcium folinate tablets.

Fluorouracil is contraindicated in patients who have any known hypersensitivity to fluorouracil, are seriously debilitated or are suffering from bone marrow depression after radiotherapy or treatment with other antineoplastic agents, or who are suffering from a potentially serious infection.
Fluorouracil is strictly contraindicated in pregnant or breast-feeding women.
Flourouracil should not be used in the management of non-malignant disease.
Fluorouracil must not be taken or used concomitantly with brivudin, sorivudine and analogues. Brivudin, sorivudine and analogues are potent inhibitors of the enzyme dihydropyrimidine dehydrogenase (DPD) which degrades fluorouracil
In patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity

Oxaliplatin is contraindicated in patients who have a known history of hypersensitivity to oxaliplatin or to any of the excipients
are breast-feeding.
have myelosuppression prior to starting first course, as evidenced by baseline neutrophils <2x109/l and/or platelet count of <100x109l.
have a peripheral sensitive neuropathy with functional impairment prior to first course.
have a severely impaired renal function (creatinine clearance less than 30 ml /min)

Chronic inflammatory bowel disease and/or bowel obstruction
History of severe hypersensitivity reactions to Irinotecan hydrochloride trihydrate or to any of the excipients
Bilirubin > 3 times the ULN
Severe bone marrow failure.
WHO performance status > 2.
Concomitant use with St John's wort

Collaborators and Investigators

Publications

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