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Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

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NCT00161642

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Lebanon, New Hampshire, 03756 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00161642
Pfizer
Completed
Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

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Study Evaluating CMD-193 in Advanced Malignant Solid Tumors
A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
Drug: CMD-193
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00161642
3152K1-100
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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