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

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
1
site
1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials