Who is sponsoring NCT05325281?

NCT05325281 is sponsored by Medical College of Wisconsin.

What drugs are being tested in NCT05325281?

Interventions in NCT05325281: CPI-613® (Dose level -1.0 250 mg/m^2), CPI-613® (Dose level 1.0 500 mg/m^2), CPI-613® (Dose level 2.0 1,000 mg/m^2), CPI-613® (Dose level 3.0 1,500 mg/m^2), CPI-613® Maximum Tolerated Dose (MTD), Gemcitabine, Intensity-modulated Radiation Therapy.

What condition does NCT05325281 study?

NCT05325281 studies Pancreas Adenocarcinoma.

Is NCT05325281 still recruiting?

NCT05325281 is currently terminated. Last updated 12 November 2025.

Last reviewed 2025-11-12 · How we verify

NCT05325281

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 12 November 2025

What this trial tests

Phase 1 trial testing CPI-613® (Dose level -1.0 250 mg/m^2) in Pancreas Adenocarcinoma in 8 participants. Terminated before completion.

Timeline

31 October 2022

Primary endpoint
8 July 2025

8 July 2025

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	31 October 2022
Primary completion	8 July 2025
Estimated completion	8 July 2025
Sites	1 location across United States

Drugs / interventions tested

CPI-613® (Dose level -1.0 250 mg/m^2)
CPI-613® (Dose level 1.0 500 mg/m^2)
CPI-613® (Dose level 2.0 1,000 mg/m^2) — full drug profile →
CPI-613® (Dose level 3.0 1,500 mg/m^2) — full drug profile →
CPI-613® Maximum Tolerated Dose (MTD) — full drug profile →
Gemcitabine (gemcitabine) — full drug profile →
Intensity-modulated Radiation Therapy

Conditions studied

Pancreas Adenocarcinoma — all drugs for Pancreas Adenocarcinoma →

Sponsor

Medical College of Wisconsin

Who can join

18 and older, any sex, with Pancreas Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Mitochondrial metabolism and cancer therapeutic innovation.
Du H, Xu T, Yu S, Wu S, et al · · 2025 · cited 43× · PMID 40754534 · DOI 10.1038/s41392-025-02311-x
Mitochondrial Metabolism: A New Dimension of Personalized Oncology.
Behnam B, Taghizadeh-Hesary F. · · 2023 · cited 25× · PMID 37627086 · DOI 10.3390/cancers15164058
Current and Emerging Treatment Options for Pancreatic Cancer: A Comprehensive Review.
Hayat U, Croce PS, Saadeh A, Desai K, et al · · 2025 · cited 17× · PMID 40004658 · DOI 10.3390/jcm14041129
Mitochondrial Metabolism in Pancreatic Ductal Adenocarcinoma: From Mechanism-Based Perspectives to Therapy.
Padinharayil H, Rai V, George A. · · 2023 · cited 12× · PMID 36831413 · DOI 10.3390/cancers15041070
Targeting Cellular Metabolism With CPI-613 Sensitizes Pancreatic Cancer Cells to Radiation Therapy.
Khan HY, Kamgar M, Aboukameel A, Bannoura S, et al · · 2023 · cited 12× · PMID 36479231 · DOI 10.1016/j.adro.2022.101122
Lipoylation inhibition enhances radiation control of lung cancer by suppressing homologous recombination DNA damage repair.
Chiang JC, Shang Z, Rosales T, Cai L, et al · · 2025 · cited 10× · PMID 40073141 · DOI 10.1126/sciadv.adt1241
The Interplay between Autophagy and Mitochondria in Cancer.
Zdanowicz A, Grosicka-Maciąg E. · · 2024 · cited 9× · PMID 39273093 · DOI 10.3390/ijms25179143
The bioenergetic landscape of cancer.
Zunica ERM, Axelrod CL, Gilmore LA, Gnaiger E, et al · · 2024 · cited 6× · PMID 38876266 · DOI 10.1016/j.molmet.2024.101966

Verify or expand the search:

Other recruiting trials for Pancreas Adenocarcinoma

Currently open trials in the same condition.

NCT07043270 — 24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC · Phase 2 · recruiting
NCT07262957 — Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Inc · Phase 4 · recruiting
NCT07081360 — Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer · Phase 3 · recruiting
NCT07022015 — Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy · NA · recruiting
NCT06497777 — The Application of DNA Nanomachines for Detecting microRNA in Blood for the Diagnosis of Pancreatic Cancer. Diagnosis of · recruiting

Other Medical College of Wisconsin trials

Trials by the same sponsor.

NCT07260552 — Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease · not yet recruiting
NCT06795360 — Weight Changes After Incretin-mimetics · NA · not yet recruiting
NCT07228208 — Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes · NA · not yet recruiting
NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
NCT07434544 — Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05325281 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 12 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05325281.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing