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
Enrollment
3
Locations
1
Arm
24
Duration (Months)
9.7
Patients Per Site
0.4
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

SiteCityStateCountryPostal Code
1TampaFloridaUnited States33612
2BaltimoreMarylandUnited States21231
3DurhamNorth CarolinaUnited States27710

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