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Sponsored by: |
CanBas Co. Ltd. |
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Information provided by: | CanBas Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT00700336 |
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 |
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Malignant Pleural Mesothelioma MPM Solid Tumors |
Drug: pemetrexed, cisplatin and CBP501 Drug: pemetrexed and cisplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
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 Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
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. |
Arm B: Active Comparator
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. |
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:
United States, Nevada | |
Nevada Cancer Institute | Recruiting |
Las Vegas, Nevada, United States, 89135 | |
Contact: Sunil Sharma, MD 702-822-5433 | |
Principal Investigator: Sunil Sharma, MD | |
United States, New Mexico | |
University of New Mexico Cancer Center | Recruiting |
Albuquerque, New Mexico, United States, 87131 | |
Contact: Claire Verschraegen 505-272-6760 | |
Principal Investigator: Claire Verschraegen, MD | |
United States, New York | |
Memorial-Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10022 | |
Contact: Lee M Krug, MD 212-639-8420 | |
Principal Investigator: Lee M Krug, MD | |
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Ctr. | Recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Contact: Chandra Belani 717-531-5471 | |
Principal Investigator: Chandra Belani, MD | |
United States, Texas | |
Cancer Therapy & Research Center | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Mita C Alain, MD 210-450-5094 | |
Contact: Tony Carmona 210-450-5979 Carmona@uthscsa.edu | |
Principal Investigator: Alain C Mita, MD, MSc |
Responsible Party: | CanBas Co. Ltd ( Takumi Kawabe, MD/CEO ) |
Study ID Numbers: | CBP08-01 |
Study First Received: | June 16, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00700336 |
Health Authority: | United States: Food and Drug Administration |
malignant pleural mesothelioma MPM solid tumors |
Folic Acid Pemetrexed Cisplatin |
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
Antimetabolites Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses |