Status:
COMPLETED
A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors
Lead Sponsor:
Synta Pharmaceuticals Corp.
Conditions:
Solid Tumor Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01183364
Start Date
July 1 2010
End Date
May 1 2013
Last Update
September 19 2014
Active Locations (1)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322