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A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute Myeloid Leukemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

A Phase 1 Dose-Escalation Study of Elesclomol Sodium Administered Intravenously to Subjects With Relapsed or Refractory Acute 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of adverse events based on frequency, causality, and severity as a measure of safety and tolerability.

Outcome Description:

- Characterize the safety and tolerability of elesclomol sodium administered to subjects with relapsed or refractory acute myeloid leukemia (AML)

Outcome Time Frame:

1 year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

Synta 4783-14

NCT ID:

NCT01280786

Start Date:

January 2011

Completion Date:

September 2012

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • leukemia
  • relapsed or refractory AML
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021