NCT00257881

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 10, 2007

Status Verified

December 1, 2007

First QC Date

November 22, 2005

Last Update Submit

December 6, 2007

Conditions

Neoplasms

Keywords

Tumor

Outcome Measures

Primary Outcomes (1)

  • Dose Limiting Toxicity, Adverse Event

Secondary Outcomes (1)

  • Pharmacokinetics parameters, Tumor assessment

Interventions

CMD-193DRUG

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant solid tumor progressed, or no standard treatment available
  • Tumor expression of Lewis Y antigen

You may not qualify if:

  • Cancer therapy within 28 days before enrollment
  • Pregnant or breastfeeding women
  • Unstable or serious concurrent medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Tokyo, Chuo-ku, 104-0045, Japan

Location

Unknown Facility

Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 22, 2005

First Posted

November 23, 2005

Study Start

November 1, 2005

Study Completion

December 1, 2006

Last Updated

December 10, 2007

Record last verified: 2007-12

Locations

JP(2)