TRIAL DETAIL

Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients

Drug:
Trial Name:
Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients
NCT#:
Conditions:
Solid Tumors
Status:
Terminated
Phase:
2
Start Date 06/01/2013
Age of Trial (yrs) 6.3
Treatment Phase:
Gleevec-resistant
Drug Category:
SDH-directed
Strategy:
Krebs cycle modulation
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
CL-CPI-613-023
Sponsor:
Cornerstone Pharmaceuticals, Inc.
Patient Contact:
King C Lee, Ph.D. 203-239-2021 king@cornerstonepharma.com Claudia B Maturo, M.Sc. 631-444-6868 claudia@cornerstonepharma.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Intravenous
Trial Notes:
This Phase II study is conducted to assess the safety and efficacy of CPI-613 in patients with advanced and/or metastatic solid tumors for whom there there is no available therapy to provide clinical benefit or for those who have refused further standard therapy. The primary outcome measure is Overall Survival (OS). The secondary outcome measures are: Response Rate (RR), Progression-Free Survival (PFS), and safety.

From Cornerstone's website:

"Altered Energy Metabolism Directed (AEMD)

Cornerstone’s proprietary AEMD small molecule compounds are believed to exploit the aberrant energy metabolism of cancer cells and its link to pathways controlling cancer cell growth, development, apoptosis and necrosis. CPI-613, the lead product candidate from the Company’s AEMD platform has undergone extensive in-vitro and in-vivo anti-tumor studies as well as animal toxicology studies which have demonstrated highly desirable characteristics that strongly warrant clinical evaluation of these agents in humans.

CPI-613 is being evaluated as a single agent therapy in Phase I/II clinical trial in multiple cancers in both the United States and Canada. The US FDA has also granted Orphan Drug Status to CPI-613 for the treatment of pancreatic cancer. Accordingly, the Company has initiated a Phase I/II trial in combination with gemcitabine for newly diagnosed pancreatic cancer patients or those with tumors intended to be treated with gemcitabine. Among the more salient AEMD compound characteristics observed in the preclinical setting are:
* A high degree of cancer cell selectivity
* Broad spectrum activity against a wide variety of cancer cell lines representing different genetic mutations, including cancer cell lines characterized as being multiple drug resistant
* A high degree of tolerability in animal models resulting in an unusually significant therapeutic index"

Trial Links

 

Trial Results

Drug Information

AEMD/CPI-613 - Manufactures website, pipeline page
 
BMC - Cancer & Metabolism - A strategically designed small molecule attacks alpha-ketoglutarate dehydrogenase in tumor cells through a redox process (full-text)
 
Forbes News - A new cancer drug worked in over 25% of patients. What does that mean?
 
A Phase I Study of the First-in-Class Anti-Mitochondrial Metabolism Agent, CPI-613, in Patients with Advanced Hematologic Malignancies
 
Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients
 
AEMD Fact Sheet
 
A Strategically designed small molecule attacks alpha-ketoglutarate dehydrogenase in tumor cells through a redox process
 

Trial Sites

Name
Address
City
State
Zip
Country
Bronx
NY
10469
USA