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

Synta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Tumor Malignancies

Treatments: Drug: STA-9090 (ganetespib) with Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01183364

9090-07

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

STA-9090 and Docetaxel

Experimental group

Description:

STA-9090 (ganetespib) and Docetaxel

Treatment:

Drug: STA-9090 (ganetespib) with Docetaxel