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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:
NCT00964873
First received: August 24, 2009
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Blast-phase Chronic Myelogenous Leukemia
AML
ALL
CML
Drug: STA-9090 (ganetespib)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:
  • To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
    as per adverse event and serious adverse event reporting


Enrollment: 29
Study Start Date: August 2009
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Part 1 Drug: STA-9090 (ganetespib)
Chemotherapy agent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964873

Locations
United States, Florida
Tampa, Florida, United States, 33612
United States, Maryland
Baltimore, Maryland, United States, 21231
United States, North Carolina
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Synta Pharmaceuticals Corp.
  More Information

No publications provided

Responsible Party: Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00964873     History of Changes
Other Study ID Numbers: 9090-04
Study First Received: August 24, 2009
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Blast-phase Chronic Myelogenous Leukemia
Synta
STA-9090
ganetespib
Hematologic Cancers
AML
ALL
CML
HSP90 Inhibitor

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Blast Crisis
Bone Marrow Diseases
Carcinogenesis
Cell Transformation, Neoplastic
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014