NCT00280631

Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Study Contact:

Study Phase:

PHASE1

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00280631

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Phase 1-2a Dose-Ranging Study of TLK199 Tablets in Myelodysplastic Syndrome (MDS)

Summary

The purpose of this study is to determine the safety and efficacy of TLK199 Tablets in patients with Myelodysplastic Syndrome (MDS)

Eligibility

Inclusion Criteria:

* Histologically confirmed diagnosis of MDS
* Documented significant cytopenia for at least 2 months
* Adequate liver and kidney function
* Ineligible for stem cell bone marrow transplantation
* At least 18 years of age
* Discontinuation of growth factors (e.g., G-CSF) within 3 weeks of study entry

Exclusion Criteria:

* Prior bone marrow transplant
* Failure to recover from any prior surgery or any major surgery within 4 weeks of study entry
* Pregnant or lactating women
* Other investigational drugs within 14 days of study entry
* Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry

Disease(s) and\or Condition(s)

Myelodysplastic Syndrome (MDS)

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Ezatiostat Hydrochlorine
- Description: Oral Tablets in 2 Divided Doses, Dose Escalation From 200 mg Per Day to 6000 mg Per Day on Days 1-7 of each 21 Day Cycle.
- Arm Group Labels: 1

Sponsor

Telik