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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML

Intervention / Treatment
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* Drug: STA-9090 (ganetespib)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Part 1<br> | Drug: STA-9090 (ganetespib)<br>* Chemotherapy agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess efficacy in subjects with AML, ALL and blast-phase CML based on standard response criteria |  | every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety and tolerability of once-weekly STA-9090 (ganetespib) in subjects with AML, ALL and blast-phase CML | as per adverse event and serious adverse event reporting | ongoing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Synta, STA-9090, ganetespib, Hematologic Cancers, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Blast-phase Chronic Myelogenous Leukemia, AML, ALL, CML, HSP90 Inhibitor