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

Sponsor

Synta Pharmaceuticals Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT01183364

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Malignancies	Drug: STA-9090 (ganetespib) with Docetaxel	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Pharmacokinetic Study of STA-9090 in Combination With Docetaxel in Subjects With Advanced Solid Tumor Malignancies

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: STA-9090 and Docetaxel STA-9090 (ganetespib) and Docetaxel	Drug: STA-9090 (ganetespib) with Docetaxel One treatment cycle will consist of weekly treatments for 2 weeks followed by a 1-week rest period. Treatment cycles will be repeated every 3 weeks. STA-9090 will be administered on Days 1 and 8 of each cycle and docetaxel will be administered on Day 1 of each cycle. Each agent will be administered as a separate 1-hour intravenous infusion.

Arm

Intervention/Treatment

Experimental: STA-9090 and Docetaxel

STA-9090 (ganetespib) and Docetaxel

Drug: STA-9090 (ganetespib) with Docetaxel

One treatment cycle will consist of weekly treatments for 2 weeks followed by a 1-week rest period. Treatment cycles will be repeated every 3 weeks. STA-9090 will be administered on Days 1 and 8 of each cycle and docetaxel will be administered on Day 1 of each cycle. Each agent will be administered as a separate 1-hour intravenous infusion.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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