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

Sponsor
Synta Pharmaceuticals Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT00964873
Collaborator
(none)
29
3
1
24
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: STA-9090 (ganetespib)
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1 Part 1

Drug: STA-9090 (ganetespib)
Chemotherapy agent

Outcome Measures

Primary Outcome Measures

  1. To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria [every 8 weeks]

Secondary Outcome Measures

  1. To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML [ongoing]

    as per adverse event and serious adverse event reporting

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tampa Florida United States 33612
2 Baltimore Maryland United States 21231
3 Durham North Carolina United States 27710

Sponsors and Collaborators

  • Synta Pharmaceuticals Corp.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00964873
Other Study ID Numbers:
  • 9090-04
First Posted:
Aug 25, 2009
Last Update Posted:
Sep 18, 2014
Last Verified:
Sep 1, 2014

Study Results

No Results Posted as of Sep 18, 2014