A Phase 1 Study of the HSP90 Inhibitor, STA-9090 in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia

September 17, 2014 updated by: Synta Pharmaceuticals Corp.

A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Subjects With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Blast-phase Chronic Myelogenous Leukemia

An open-label phase 1 study to assess safety and efficacy of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
    • Maryland
      • Baltimore, Maryland, United States, 21231
    • North Carolina
      • Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with a pathologic confirmation of the diagnosis of AML, ALL, or blast-phase CML
  • ECOG Performance Status 0-2
  • Adequate organ function as defined in the protocol.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Hyperleukocytosis
  • Acute Promyelocytic Leukemia (FAB-M3) subtype
  • Uncontrolled Disseminated Intravascular Coagulation (DIC)
  • Active central nervous system leukemia
  • Concomitant radiation therapy, chemotherapy, or immunotherapy
  • Women who are pregnant or lactating
  • Neuropathy ≥ grade 2 (NCI CTCAE) at time of enrollment
  • Chemotherapy (with the exception of hydroxyurea) or radiotherapy within two weeks or within six times the agent's half life
  • Require ongoing therapy with either G- or GM-CSF, or long-acting versions of these molecules
  • Use of any investigational agents within two weeks or within six times the agent's half life --Treatment with chronic immunosuppressants
  • Other medical/psychiatric condition that may increase the risk associated with study participation as defined by the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Part 1
Drug: STA-9090 (ganetespib)
Chemotherapy agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria
Time Frame: every 8 weeks
every 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML
Time Frame: ongoing
as per adverse event and serious adverse event reporting
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9090-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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