Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Irinotecan

Bevacizumab

Leucovorin

Fluorouracil

Oxaliplatin

Folfirinox

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

CPI-613

Irinotecan: 150mg/m2 IV over 90 min-14 day cycle Leucovorin: 400mg/m2 IV over 2hrs with Irinotecan-14 day cycle Oxaliplatin: 85mg/m2 IV over 2hrs-14 day cycle 5FU: 2400mg/m2 IV over 46-48 hrs-14 day cycle

modified FFX

Pre-clinical in vitro and in vivo data as well as early phase 1 clinical trials have shown that both hematologic and solid tumor cells are susceptible to single-agent cytotoxicity by CPI-613 (devimistat), consistent with its selective target of the altered form of mitochondrial energy metabolism in tumor cells, causing changes in mitochondrial enzyme activities and redox status, which lead to apoptosis, necrosis, and autophagy of tumor cells leading to the death of cancer cells. It is our hypothesis that CPI-613 (devimistat) will enhance the efficacy of mFOLFIRINOX plus Bevacizumab when given as a combination treatment. The study will follow a standard 3+3 design. Cohorts of three to six patients will be treated at each dose level until the MTD is defined.

CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

Phase I Study of the First-In-Class Agent CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

Number of patients with Dose-limiting toxicities (DLT) will be assessed in order to be able to establish safety and tolerability for the combination of CPI-613, mFFX with bevacizumab therapy. Using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for adverse event reporting (Grade 1 (Mild) - 5 (Death) as well as expectedness (unexpected/expected) and attribution (definitely related to study treatment to unrelated to study treatment).

Dose-limiting toxicities assessed in order to be able to establish safety and tolerability for the combination of CPI-613, mFFX with bevacizumab therapy. Using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for adverse event reporting (Grade 1 (Mild) - 5 (Death) as well as expectedness (unexpected/expected) and attribution (definitely related to study treatment to unrelated to study treatment).

Determine recommended phase 2 dose (RP2D) of CPI-613 (devimistat) (MTD) in combination with mFOLFIRINOX plus bevacizumab

It is defined as the proportion of patients who achieve complete response or partial response during or following study treatment

Defines as the time from enrollment to the date of death due to any cause.

Cornerstone Pharmaceuticals

Symptoms and General Pathology

Neoplasm Metastasis

Capecitabine

Antimetabolites

Oxaliplatin (Eloxatin)

Capecitabine (Xeloda)

Per Pfeiffer, MD

XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).

Bloodsamples will be collected and frozen and later examined for potential predictive factors

XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer

XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study

Odense University Hospital

Professor, M.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer	NCT05070104	C04.588.274.476...	CPI-613 modified FFX Bevacizumab	18 Years -	Cornerstone Pharmaceuticals
CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer	NCT05070104	C04.588.274.476...	CPI-613 modified FFX Bevacizumab	18 Years -	Cornerstone Pharmaceuticals
CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer	NCT05070104	C04.588.274.476...	CPI-613 modified FFX Bevacizumab	18 Years -	Cornerstone Pharmaceuticals
XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer	NCT00212615	C04.588.274.476...	Oxaliplatin (El... Capecitabine (X...	18 Years -	Odense University Hospital
CPI-613 (Devimistat) in Combination With Modified FOLFIRINOX Plus Bevacizumab in Patients With Metastatic Colorectal Cancer	NCT05070104	C04.588.274.476...	CPI-613 modified FFX Bevacizumab	18 Years -	Cornerstone Pharmaceuticals

Spots Global Cancer Trial Database for c04.588.274.476.411.307