Study Evaluating CMD-193 in Advanced Malignant Solid Tumors
NCT00161642
ABOUT THIS STUDY
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- Histologically confirmed malignant solid tumor that has progressed following standard therapy, or for which no standard effective treatment is available
- Tumor expression of Lewis Y antigen ( > or = 20% tumor cells positive for Lewis Y by immunohistochemistry assay)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Chemotherapy, radiation therapy, other cancer therapy, or investigational agents
within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy
included nitrosoureas or mitomycin C)
- Symptomatic or clinically active CNS metastases. Subjects who have had prior treatment
with radiotherapy or surgical resection for CNS metastases will be permitted if CNS
metastases have remained stable and have not required any treatment for at least 3
months prior to the first dose of CMD-193.
- Significant prior allergic reaction to recombinant human or murine proteins
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating CMD-193 in Advanced Malignant Solid Tumors | |||
Official Title ICMJE | A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors. | |||
Brief Summary | The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of CMD-193. Preliminary information about how a person's body processes CMD-193 and how CMD-193 affects tumors will also be collected. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Neoplasms | |||
Intervention ICMJE | Drug: CMD-193 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 54 | |||
Original Enrollment ICMJE | 68 | |||
Actual Study Completion Date ICMJE | July 2007 | |||
Actual Primary Completion Date | July 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00161642 | |||
Other Study ID Numbers ICMJE | 3152K1-100 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |