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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 and tolerability of the treatment will also be evaluated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Synta Pharmaceuticals Corp.
• Treatments: Docetaxel

Criteria

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