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

NCT00964873 | Completed Phase 1

• 1 other identifier: 9090-04
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  every 8 weeks

Secondary Outcomes (1)

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

  ongoing

Study Arms (1)

1 Part 1

EXPERIMENTAL

Drug: STA-9090 (ganetespib)

Interventions

STA-9090 (ganetespib) DRUG

Chemotherapy agent

1 Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (3)

Unknown Facility

Tampa, Florida, 33612, United States

Location

Unknown Facility

Baltimore, Maryland, 21231, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Blast Crisis

Interventions

STA 9090

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2011
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (3)