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NCT00035867 Clinical Trial

Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00035867
Other study ID # TLK199.1001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 6, 2002
Last updated May 30, 2008
Start date April 2002
Est. completion date May 2007

Study information
Verified date June 2005
Source Telik
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• TLK199 HCl Liposomes for Injection

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Chicago Chicago Illinois
United States Texas Cancer Associates Dallas Texas
United States M.D. Anderson Cancer Center Houston Texas
United States The Angeles Clinic & Research Institute Los Angeles California
United States The Sarah Cannon Cancer Center Nashville Tennessee
United States Oregon Health & Science University Portland Oregon
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Midwest Cancer Research Group Skokie Illinois

Sponsors (1)
Lead Sponsor Collaborator
Telik

Country where clinical trial is conducted

United States, 

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