Study Elesclomol Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Synta Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Elesclomol Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01280786

Synta 4783-14

Details and patient eligibility

About

This is a phase 1 study to test the safety of escalating doses of elesclomol sodium given to patients with advanced myeloid leukemia.

Full description

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Elesclomol Sodium

Experimental group

Treatment:

Drug: Elesclomol Sodium