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Completed

NCT Number: NCT00161642

Study Evaluating CMD-193 in Advanced Malignant Solid Tumors

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lebanon, New Hampshire, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMD-193

Drug

Primary outcomes

  1. Physical examinations

  2. hematology panels

  3. ECG

Secondary outcomes

  1. Radiographic tumor evaluations

  2. blood sampling for pharmacokinetic assessments

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Phase 1 Dose Escalation Study of CMD-193 in Subjects With Advanced Malignant Tumors.

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Sep 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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