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

NCT ID: NCT00257881

Last Updated: 2007-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Keywords

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Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CMD-193

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Tokyo, Chuo-ku, Japan

Site Status

Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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3152K1-101

Identifier Type: -

Identifier Source: org_study_id