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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

Primary Purpose

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
STA-9090 (ganetespib)
Sponsored by
Synta Pharmaceuticals Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Synta, STA-9090, ganetespib, Hematologic Cancers, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML, HSP90 Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1 Part 1

Arm Description

Outcomes

Primary Outcome Measures

To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2009
Last Updated
September 17, 2014
Sponsor
Synta Pharmaceuticals Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT00964873
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synta Pharmaceuticals Corp.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML
Keywords
Synta, STA-9090, ganetespib, Hematologic Cancers, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML, HSP90 Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Part 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
STA-9090 (ganetespib)
Intervention Description
Chemotherapy agent
Primary Outcome Measure Information:
Title
To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria
Time Frame
every 8 weeks
Secondary Outcome Measure Information:
Title
To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML
Description
as per adverse event and serious adverse event reporting
Time Frame
ongoing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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