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A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Physical examinations

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3152K1-100

NCT ID:

NCT00161642

Start Date:

November 2004

Completion Date:

July 2007

Related Keywords:

  • Neoplasms
  • Malignant Tumors
  • Neoplasms

Name

Location

Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Lebanon, New Hampshire