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

Completed · Phase 1

Conditions studied: Solid Tumor Malignancies

In brief

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.

Key facts

Study ID

NCT01183364

Run by

Synta Pharmaceuticals Corp.

People needed

27

Starts

2010-07-01

Expected to finish

2013-05-01

Last updated by the study team

2014-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University School of Medicine — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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