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Sponsored by: |
Cornerstone Pharmaceuticals, Inc. |
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Information provided by: | Cornerstone Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00741403 |
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 |
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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 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Advanced Cancer: Experimental IV injection of CPI-613 on Days 1, 3,8,10,15,17 of 28 day cycle in patients with advanced malignancies
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Drug: CPI-613
CPI-613, the investigational drug, is a novel anti-tumor compound presumably with a novel mechanism of action that does not belong to any existing pharmacological class of anticancer agents currently used in the clinics. Specifically, CPI-613 is referred to as an Altered Energy Metabolism-Directed (AEMD) compound, and it is selective against tumor cells (but not normal cells) according to preclinical studies.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard A. Lutes, M.D. | 203-262-1232 | richard@cornerstone.com |
United States, California | |
Tower Cancer Research | Recruiting |
Beverly Hills, California, United States, 90211 | |
Contact: Peter Rosen, MD | |
Contact: Marie Fuerst, MS RN 310-285-7269 | |
Principal Investigator: Peter Rosen, MD | |
Canada, British Columbia | |
British Columbia Cancer Center | Not yet recruiting |
Vancouver, British Columbia, Canada | |
Contact: Karen Gelmon, MD 604-877-6000 ext 2032 | |
Principal Investigator: Karen Gelmon, MD | |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Lillian Siu, MD FRCPC 416-946-2911 | |
Principal Investigator: Lillian Siu, MD FRCPC |
Principal Investigator: | Lillian Siu, M.D. FRCPC | Princess Margaret Hospital, Canada |
Responsible Party: | Cornerstone Pharmaceutiecals, Inc ( Richard Lutes, MD ) |
Study ID Numbers: | CL-CPI-613-002 |
Study First Received: | August 25, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00741403 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Phase I Phase II malignancies refractory relapsed |
Lymphatic Diseases Immunoproliferative Disorders Neoplasm Metastasis Lymphoproliferative Disorders Lymphoma |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Histologic Type Immune System Diseases |