A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors

Study Overview
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Brief Summary
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This is an open-label, Phase 1, dose-escalation study to determine the recommended doses of STA-9090 (ganetespib) and docetaxel for the treatment of subjects with solid tumor malignancies. The safety and tolerability of the treatment will also be evaluated.

Official Title
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A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies

Conditions
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Solid Tumor Malignancies

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have histologically confirmed metastatic or unresectable malignancy with evidence of progression If subject has been treated with docetaxel, must have evidence of persistent or progressive disease Measurable disease per RECIST CNS metastases are permitted if treated and radiographically and clinically stable for 4 weeks prior to first dose ECOG status less than or equal to 2 Life expectancy greater than 3 months Adequate hematological, hepatic and renal function as defined by protocol Willingness and ability to comply with study requirements Female subjects of childbearing age must have a negative pregnancy test at study entry Female subjects of child bearing age and males must agree to use adequate contraception as defined in the protocol Exclusion Criteria: Prior chemotherapy or investigational agents within 3 weeks or 5 times the agent's half life, whichever is shorter prior to first dose Radiotherapy within 2 weeks of first dose Surgery, radiotherapy or ablative procedure to the only area of measurable disease Major surgery within 4 weeks of first dose Poor venous access that would require an indwelling catheter for study drug administration History of severe allergic or hypersensitivity reactions to STA-9090 or docetaxel or their diluents or excipients Baseline QTc >470 msec or previous history of QT prolongation while taking other medications Peripheral neuropathy > Grade 1 Ventricular ejection fraction less than or equal to 55% at baseline Treatment with chronic immunosuppressants. However subjects may receive steroids for stable CNS metastases Women who are pregnant or lactating Uncontrolled intercurrent illness

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: STA-9090 and Docetaxel<br>STA-9090 (ganetespib) and Docetaxel | Drug: STA-9090 (ganetespib) with Docetaxel<br>* One treatment cycle will consist of weekly treatments for 2 weeks followed by a 1-week rest period. Treatment cycles will be repeated every 3 weeks. STA-9090 will be administered on Days 1 and 8 of each cycle and docetaxel will be administered on Day 1 of each cycle. Each agent will be administered as a separate 1-hour intravenous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of STA-9090 (ganetespib) and docetaxel combination | The number of adverse events will be used as a measure of safety | June 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Pharmacokinetics of STA-9090 (ganetespib) and Docetaxel. This includes concentrations of these drugs in patients' blood at various protocol-specified times relative to the time of dose administration. These will be summarized by parameters including maximum concentration, total exposure and how fast the patient's body gets rid of the drug (known as Cmax, AUC, t1/2, respectively). | June 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid tumor malignancies, tumor, cancer, STA-9090, ganetespib, HSP90 inhibitor