A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2009 |
| End Date: | May 2011 |
The objectives of this study are:
- To determine the safety and MTD of CPI-613, when used in combination with Gemcitabine,
in cancer patients.
- To compare the safety and efficacy of CPI-613/Gemcitabine combination vs. Gemcitabine
alone in patients with carcinoma of the pancreas.
CPI-613, the investigational drug, is a novel anti-tumor compound believed to operate via a
novel mechanism of action that does not belong to any existing pharmacological class of
anticancer agents currently being used in the clinics. Specifically, CPI-613 is Cornerstone
Pharmaceutical Inc.'s lead drug from its Altered Energy Metabolism-Directed (AEMD)
technology platform. It is selective against tumor cells (but not normal cells)according to
preclinical studies.
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