A Dose Escalation Study of STA-9090 and Docetaxel in Patients With Solid Tumors
Status: | Completed |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2014 |
Start Date: | July 2010 |
End Date: | October 2012 |
Contact: | Kelly Maslin |
Email: | kmaslin@syntapharma.com |
Phone: | 781-541-7150 |
A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies
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.
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.
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
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