NCT00161642

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2004

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

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, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

Enrollment Period

2.7 years

First QC Date

September 7, 2005

Last Update Submit

September 9, 2009

Conditions

Neoplasms

Keywords

Malignant Tumors

Outcome Measures

Primary Outcomes (3)

  • Physical examinations

  • hematology panels

  • ECG

Secondary Outcomes (2)

  • Radiographic tumor evaluations

  • blood sampling for pharmacokinetic assessments

Interventions

CMD-193DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Lebanon, New Hampshire, 03756, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19111, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

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

September 7, 2005

First Posted

September 12, 2005

Study Start

November 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

US(3)