Study of STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

Study Overview
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Brief Summary
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An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Detailed Description
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This is an open-label Phase 1 dose-escalation study in patients with solid tumors treated with STA-9090 (ganetespib) to evaluate for safety, tolerance and efficacy.

Official Title
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A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice-Weekly in Patients With Solid Tumors

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: STA 9090 (ganetespib)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be documented to be refractory or not candidates for current approved therapies. - Must have anECOG status 0-2. - Peripheral neuropathy ?2. Must have acceptable organ and marrow function per protocol parameters. No clinically significant ventricular arrythmias or ischemia. Exclusion Criteria: Must not be pregnant or breastfeeding. -No chemotherapy or radiation within 3 weeks.. No previous radiation to >25% of total bone marrow. No previous high dose chemotherapy with autologous or allogeniec hematopoietic stem cell transplantation. No primary brain tumors or active brain metastases. No use of any investigational agents within 4 weeks. No treatment with chronic immunosuppressants. No uncontrolled, intercurrent illness.

Ages Eligible for Study
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Minimum Age: 25 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ganetespib<br> | Drug: STA 9090 (ganetespib)<br>* This is a dose-escalation study. The first cohort will consist of three patients who will receive 2 mg/m2 of STA 9090 (ganetespib) during a 1-hour infusion 2 times per week (e.g., [Monday, Thursday] or [Tuesday, Friday]) for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive 4, 7, 10, 14, 19, 25, 33, 40 and 48 mg/m2 provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Further dose increments will be approximately 20% over the previous dose level, until the maximum tolerated dose (MTD) is determined.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities and evaluation of Adverse Events in relation to Study Drug. |  | Cycle 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic cancer, solid tumor, histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable, STA-9090, ganetespib