Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telik

Criteria

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