Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Telik

Status and phase: Completed; Phase 2; Phase 1

Conditions: Myelodysplastic Syndromes

Treatments: Drug: TLK199 HCl Liposomes for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035867

TLK199.1001

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)