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| Sponsor: | Cornerstone Pharmaceuticals, Inc. |
|---|---|
| Information provided by (Responsible Party): | 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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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| United States, Arizona | |
| Pivotal Research Centers | |
| Peoria, Arizona, United States, 85381 | |
| United States, New York | |
| Eastchester Center for Cancer Care | |
| Bronx, New York, United States, 10469 | |
| United States, Texas | |
| Mary Crowley Cancer Research Centers | |
| Dallas, Texas, United States, 75201 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada | |
| 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 |
| Principal Investigator: | Senzer Neil, M.D. | Mary Crowley Cancer Research Centers |
More Information
| Responsible Party: | Cornerstone Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00741403 History of Changes |
| Other Study ID Numbers: | CL-CPI-613-002 |
| Study First Received: | August 25, 2008 |
| Last Updated: | January 23, 2012 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Phase I Phase II malignancies refractory relapsed |
|
Neoplasms Lymphoma Neoplasm Metastasis Neoplasms, Second Primary Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes |