Neoplasms
Conditions
Keywords
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.
Interventions
DRUGCMD-193
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical examinations | — |
| hematology panels | — |
| ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic tumor evaluations | — |
| blood sampling for pharmacokinetic assessments | — |
Countries
United States
Outcome results
None listed