NCT02232152

CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

Completed Phase 1 Last updated 7 August 2023

What this trial tests

Phase 1 trial testing 6,8-bis(benzylthio)octanoic acid in Mucinous Adenocarcinoma of the Colon in 19 participants. Completed in 11 January 2023.

Timeline

6 January 2015

Primary endpoint
19 February 2019

11 January 2023

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	6 January 2015
Primary completion	19 February 2019
Estimated completion	11 January 2023
Sites	1 location across United States

Drugs / interventions tested

• 6,8-bis(benzylthio)octanoic acid — full drug profile →
• fluorouracil — full drug profile →
• pharmacological study — full drug profile →
• laboratory biomarker analysis — full drug profile →

Conditions studied

• Mucinous Adenocarcinoma of the Colon — all drugs for Mucinous Adenocarcinoma of the Colon →
• Mucinous Adenocarcinoma of the Rectum — all drugs for Mucinous Adenocarcinoma of the Rectum →
• Recurrent Colon Cancer — all drugs for Recurrent Colon Cancer →
• Recurrent Rectal Cancer — all drugs for Recurrent Rectal Cancer →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Mucinous Adenocarcinoma of the Colon or Mucinous Adenocarcinoma of the Rectum. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot phase I trial studies the side effects and best dose of CPI-613 when given together with fluorouracil in treating patients with colorectal cancer that has spread to other parts of the body and cannot be removed by surgery. CPI-613 may kill tumor cells by turning off their mitochondria. Mitochondria are used by tumor cells to produce energy and are the building blocks needed to make more tumor cells. By shutting off these mitochondria, CPI-613 deprives the tumor cells of energy and other supplies that they need to survive and grow in the body. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving CPI-613 with fluorouracil may kill more tumor cells.

Publications & conference data

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

1. The emerging role and targetability of the TCA cycle in cancer metabolism.
   Anderson NM, Mucka P, Kern JG, Feng H. · · 2018 · cited 404× · PMID 28748451 · DOI 10.1007/s13238-017-0451-1
2. Reactive Oxygen Species in the Tumor Microenvironment: An Overview.
   Weinberg F, Ramnath N, Nagrath D. · · 2019 · cited 301× · PMID 31426364 · DOI 10.3390/cancers11081191
3. Mitochondria in cancer.
   Grasso D, Zampieri LX, Capelôa T, Van de Velde JA, et al · · 2020 · cited 168× · PMID 32548570 · DOI 10.15698/cst2020.06.221
4. Communication in the Cancer Microenvironment as a Target for Therapeutic Interventions.
   Dominiak A, Chełstowska B, Olejarz W, Nowicka G. · · 2020 · cited 134× · PMID 32422889 · DOI 10.3390/cancers12051232
5. Targeting hypoxic response for cancer therapy.
   Paolicchi E, Gemignani F, Krstic-Demonacos M, Dedhar S, et al · · 2016 · cited 73× · PMID 26859576 · DOI 10.18632/oncotarget.7229
6. Mitochondrial function and gastrointestinal diseases.
   Haque PS, Kapur N, Barrett TA, Theiss AL. · · 2024 · cited 51× · PMID 38740978 · DOI 10.1038/s41575-024-00931-2
7. Targeting Altered Energy Metabolism in Colorectal Cancer: Oncogenic Reprogramming, the Central Role of the TCA Cycle and Therapeutic Opportunities.
   Neitzel C, Demuth P, Wittmann S, Fahrer J. · · 2020 · cited 51× · PMID 32610612 · DOI 10.3390/cancers12071731
8. Mitochondria in cancer metabolism, an organelle whose time has come?
   Anderson RG, Ghiraldeli LP, Pardee TS. · · 2018 · cited 49× · PMID 29807044 · DOI 10.1016/j.bbcan.2018.05.005