Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 12:25 AM
Study NCT ID:
NCT00907166
Status:
TERMINATED
Last Update Posted:
2017-03-21
First Post:
2009-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients
Sponsor:
Cornerstone Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase I/II Open-Label Dose-Escalation Clinical Trial of CPI-613 in Combination With Gemcitabine in Cancer Patients
Status:
TERMINATED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Suspended trial was not restarted.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
* 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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: