Study Evaluating Intravenous CMD-193 in Subjects With Advanced Malignant Solid Tumors

Phase 1TerminatedNCT00257881

Wyeth is now a wholly owned subsidiary of Pfizer46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms

Interventions

CMD-193DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Malignant solid tumor progressed, or no standard treatment available * Tumor expression of Lewis Y antigen Exclusion Criteria: * Cancer therapy within 28 days before enrollment * Pregnant or breastfeeding women * Unstable or serious concurrent medical conditions

Locations (2)

Unnamed facility

Tokyo, Chuo-ku, Japan

Unnamed facility

Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

Outcomes

Primary Outcomes

Dose Limiting Toxicity, Adverse Event

Secondary Outcomes

Pharmacokinetics parameters, Tumor assessment

Data from ClinicalTrials.gov

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