Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2014 |
| Start Date: | January 2011 |
| End Date: | September 2012 |
| Contact: | Joelle Lufkin, MPH |
| Email: | jlufkin@syntapharma.com |
| Phone: | 781 541 7141 |
A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia
This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to
patients with advanced myeloid leukemia.
patients with advanced myeloid leukemia.
This aim of this study is to determine the safety and tolerability of elesclomol sodium at
escalating doses (ultimately identifying the maximum tolerated dose) when administered to
patients with advanced myeloid leukemia.
escalating doses (ultimately identifying the maximum tolerated dose) when administered to
patients with advanced myeloid leukemia.
Inclusion Criteria:
- Adults with cytologically confirmed Acute Myeloid Leukemia (AML) that has relapsed
after the completion of induction and/or consolidation therapy or has failed to
respond to standard induction therapy
- ECOG performance status of 0-2
- Acceptable organ and marrow function during the screening period as defined by the
protocol
- Reliable venous access suitable for study drug infusions
Exclusion Criteria:
- Significant cardiovascular disease
- Candidates for hematopoietic stem cell transplant
- Women who are pregnant or breast-feeding
- Prior treatment with chronic immunosuppressants
- Other clinically significant uncontrolled conditions
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Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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