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

NCT ID: NCT01280786

Last Updated: 2014-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elesclomol Sodium

Group Type EXPERIMENTAL

Elesclomol Sodium

Intervention Type DRUG

Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.

Interventions

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Elesclomol Sodium

Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Synta 4783-14

Identifier Type: -

Identifier Source: org_study_id

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