CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma

Summary

This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly with chemoradiation for local control of pancreatic adenocarcinoma (PDAC).

Conditions

• Pancreas Adenocarcinoma

Interventions

DRUG

CPI-613® (Dose level -1.0 250 mg/m^2)

CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

DRUG

CPI-613® (Dose level 1.0 500 mg/m^2)

CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

DRUG

CPI-613® (Dose level 2.0 1,000 mg/m^2)

CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

DRUG

CPI-613® (Dose level 3.0 1,500 mg/m^2)

CPI-613® is a mitochondrial metabolism inhibitor. CPI-613® is a lipoic acid antagonist that abrogates mitochondrial energy metabolism to induce apoptosis in various cancer cells.

DRUG

CPI-613® Maximum Tolerated Dose (MTD)

MTD will be determined by testing increasing doses of CPI-613®, starting from 500 mg/m\^2 and up to 1,500 mg/m\^2, on dose escalation cohorts of three patients (maximum 24 patients) in combination with Gem-RT therapy. MTD reflects the highest drug dose that does not cause unacceptable adverse effects, with a target dose-limiting toxicity (DLT) rate of 30%. Final dose will be revised as appropriate.

DRUG

Gemcitabine

Subjects will be administered 400 mg/m\^2 gemcitabine once per week by IV infusion over approximately 30 minutes for six weeks.

RADIATION

Intensity-modulated Radiation Therapy

1.8 Gy per fraction, 5 fractions per week, 30 fractions total (54 Gy) across six weeks.

Sponsors & Collaborators

• Cornerstone Pharmaceuticals

  collaborator INDUSTRY

• Barbara Ann Karmanos Cancer Institute

  collaborator OTHER

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Mandana Kamgar, MD, MPH · Medical College of Wisconsin

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-31

Primary Completion

2025-07-08

Completion

2025-07-08

FDA Drug

Yes

Countries

• United States

Study Locations