Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).

Completed

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Histologically or cytologically confirmed diagnosis of MDS
Adequate liver and kidney function
Ineligible for, or refusing, allogeneic bone marrow transplant
At least 18 years of age
Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry

Exclusion criteria

Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
Pregnant or lactating women
History of allergy to eggs
Other investigational drugs within 14 days of study entry
Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
Concomitant steroids or hormones for the treatment of neoplasms

Treatment and study plan

TLK199 HCl Liposomes for Injection

Drug

Sponsors and collaborators

Lead sponsor

Telik

Industry

Registry information

Official study title

Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Important dates

Study start: 2002
Study completion: 2007
First posted: May 7, 2002
Registry last updated: Jun 3, 2008

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.

Published trials that share one or more normalized conditions with this study.

Completed