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| Sponsor: | CanBas Co. Ltd. |
|---|---|
| Information provided by (Responsible Party): | CanBas Co. Ltd. |
| ClinicalTrials.gov Identifier: | NCT00700336 |
Purpose
The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial.
The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Pleural Mesothelioma Solid Tumors |
Drug: pemetrexed, cisplatin and CBP501 Drug: pemetrexed and cisplatin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin in Patients With Advanced Solid Tumors and in Chemotherapy-naïve Patients With Malignant Pleural Mesothelioma |
| Estimated Enrollment: | 72 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
pemetrexed, cisplatin and CBP501
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Drug: pemetrexed, cisplatin and CBP501
CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP. Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL. Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration. Other Name: (ALIMTA)
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Active Comparator: Arm B
pemetrexed and cisplatin
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Drug: pemetrexed and cisplatin
Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL. Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration. Other Name: (ALIMTA)
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Phase I: Histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy
Phase II: Histologically or cytologically confirmed diagnosis of malignant pleural mesothelioma (MPM), not amenable for radical resection, who has not received previous chemotherapy or other systemic treatment
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic | |
| Scottsdale, Arizona, United States | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States | |
| United States, California | |
| City of Hope | |
| Duarte, California, United States | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States | |
| United States, Michigan | |
| Karmanos Cancer Institute/Wayne State University | |
| Detroit, Michigan, United States | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Memorial-Sloan Kettering Cancer Center | |
| New York, New York, United States, 10022 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States | |
| United States, Pennsylvania | |
| Penn State Milton S. Hershey Medical Ctr. | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Texas | |
| Cancer Therapy & Research Center | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States | |
More Information
| Responsible Party: | CanBas Co. Ltd. |
| ClinicalTrials.gov Identifier: | NCT00700336 History of Changes |
| Other Study ID Numbers: | CBP08-01 |
| Study First Received: | June 16, 2008 |
| Last Updated: | October 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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malignant pleural mesothelioma solid tumors |
|
Mesothelioma Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial Pemetrexed Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |