TRIAL DETAIL
Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients
Drug: |
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Trial Name: |
Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients |
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NCT#: |
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Conditions: |
Solid Tumors |
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Status: |
Terminated |
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Phase: |
2 |
Start Date 06/01/2013 |
Age of Trial (yrs) 10.9 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
SDH-directed |
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Strategy: |
Krebs cycle modulation |
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Trial Type: |
GIST not specified. GIST patient enrollment unknown. |
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Other Protocol IDs: |
CL-CPI-613-023 |
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Sponsor: |
Cornerstone Pharmaceuticals, Inc. |
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Patient Contact: |
King C Lee, Ph.D.
203-239-2021
king@cornerstonepharma.com
Claudia B Maturo, M.Sc.
631-444-6868
claudia@cornerstonepharma.com |
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Intravenous |
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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" |
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Trial Links |
Trial Results |
Trial Sites
Name |
Address |
City |
State |
Zip |
Country |
Bronx |
NY |
10469 |
USA |