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| Sponsor: | Cornerstone Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Cornerstone Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00741403 |
Purpose
An open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose (MTD), efficacy, and pharmacokinetics (PKs) of CPI-613 given twice weekly for three consecutive weeks in cancer patients
The objectives of this study are:
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer Metastatic Cancer Lymphoma Solid Tumors Advanced Malignancies |
Drug: CPI-613 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open Label, Dose-Escalation Study to Evaluate Safety, Tolerability, Maximum Tolerated Dose (MTD), Efficacy, and Pharmacokinetics (PKs) of CPI-613 Given Twice Weekly for Three Consecutive Weeks in Cancer Patients |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
IV Infusion of CPI-613 on Days 1,4,8,11,15,18 of 28 day cycle in patients with advanced malignancies
|
Drug: CPI-613
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values ≤2 weeks must be:
Exclusion Criteria:
Contacts and Locations| Contact: King Lee, Ph.D., R.A.C. | 631-444-6868 | King@cornerstonepharma.com |
| United States, Arizona | |
| Pivotal Research Centers | Recruiting |
| Peoria, Arizona, United States, 85381 | |
| Contact: Jamie Smith 623-815-9714 jsmith@pivotalresearch.com | |
| Principal Investigator: Divis K Khaira, M.D. | |
| United States, New York | |
| Eastchester Center for Cancer Care | Recruiting |
| Bronx, New York, United States, 10469 | |
| Contact: Karen Hoffman, M.D. 718-732-4029 Karen@eastchestercenter.com | |
| Principal Investigator: Avi Retter, M.D. | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Karen Gelmon, MD 604-877-6000 ext 2032 | |
| Principal Investigator: Karen Gelmon, MD | |
| Principal Investigator: | Karen Gelmon, M.D. | British Columbia Cancer Agency |
| Principal Investigator: | Avi Retter, M.D. | Eastchester Center for Cancer Care |
| Principal Investigator: | Divis K Khaira, M.D. | Pivotal Research Centers |
More Information
| Responsible Party: | Cornerstone Pharmaceuticals, Inc ( King Lee, Ph.D., R.A.C. ) |
| Study ID Numbers: | CL-CPI-613-002 |
| Study First Received: | August 25, 2008 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00741403 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Phase I Phase II malignancies refractory relapsed |
|
Lymphatic Diseases Neoplastic Processes Neoplasms Pathologic Processes Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Neoplasm Metastasis Lymphoproliferative Disorders Lymphoma |