STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders

Sponsor
Synta Pharmaceuticals Corp. (Industry)
Overall Status
Completed
CT.gov ID
NCT00858572
Collaborator
(none)
31
Enrollment
3
Locations
1
Arm
47.1
Duration (Months)
10.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: STA-9090 (ganetespib)
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
31 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 Twice Weekly in Subjects With Hematologic Malignancies
Study Start Date :
Mar 1, 2009
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cohort

Drug: STA-9090 (ganetespib)
Chemotherapy agent

Outcome Measures

Primary Outcome Measures

  1. To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies [Feb 2011]

  2. To assess preliminary evidence of anti-neoplastic activity [Feb 2011]

  3. To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion [Feb 2011]

Secondary Outcome Measures

  1. To assess changes in biomarkers following study drug administration [Feb 2011]

  2. To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters [Feb 2011]

  3. To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib) [Feb 2011]

Eligibility Criteria

Criteria

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

Inclusion Criteria

  • Males and females 18 years or older

  • Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol

  • Must have acceptable organ function during screening as defined in the protocol

Exclusion Criteria

  • Pregnant or breast-feeding women

  • Patients must meet the washout periods for prior chemotherapies and radiation

  • History of stroke within 6 months of treatment

  • Poor venous access for study drug administration

  • Treatment with chronic immunosuppressants

  • Other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1BostonMassachusettsUnited States02115
2New YorkNew YorkUnited States10065
3San AntonioTexasUnited States78229

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:
NCT00858572
Other Study ID Numbers:
  • 9090-03
First Posted:
Mar 10, 2009
Last Update Posted:
Sep 18, 2014
Last Verified:
Sep 1, 2014
Keywords provided by Synta Pharmaceuticals Corp.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2014