Study Evaluating Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors
This study has been terminated.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00257881
First received: November 22, 2005
Last updated: December 6, 2007
Last verified: December 2007
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 22, 2005 | ||||
| Last Updated Date | December 6, 2007 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Dose Limiting Toxicity, Adverse Event | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00257881 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Pharmacokinetics parameters, Tumor assessment | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Evaluating Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors | ||||
| Official Title ICMJE | Phase 1 Dose-Escalation Study of Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors | ||||
| Brief Summary | The primary purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of CMD-193 administered intravenously (IV) to subjects with advanced malignant tumors. The secondary purpose is to obtain preliminary information on the pharmacokinetics and antitumor activity of IV CMD-193. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neoplasms | ||||
| Intervention ICMJE | Drug: CMD-193 | ||||
| Study Arm (s) | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 46 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 74 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00257881 | ||||
| Other Study ID Numbers ICMJE | 3152K1-101 | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | |||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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