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

Phase 1

Completed

• Conditions: Solid Tumor Malignancies
• Interventions: Drug: STA-9090 (ganetespib) with Docetaxel

• Registration Number: NCT01183364
• Lead Sponsor: Synta Pharmaceuticals Corp.

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 and tolerability of the treatment will also be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2013-03
• Study Completion: 2013-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STA-9090 and Docetaxel	STA-9090 (ganetespib) with Docetaxel	STA-9090 (ganetespib) and Docetaxel

Primary Outcome Measures

Name	Time	Method
Safety of STA-9090 (ganetespib) and docetaxel combination	June 2011	The number of adverse events will be used as a measure of safety

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	June 2011	Pharmacokinetics of STA-9090 (ganetespib) and Docetaxel. This includes concentrations of these drugs in patients' blood at various protocol-specified times relative to the time of dose administration. These will be summarized by parameters including maximum concentration, total exposure and how fast the patient's body gets rid of the drug (known as Cmax, AUC, t1/2, respectively).

Trial Locations

Locations (1)

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States