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

NCT ID: NCT01183364

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-05-31

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.

Conditions

Solid Tumor Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STA-9090 and Docetaxel

STA-9090 (ganetespib) and Docetaxel

Group Type: EXPERIMENTAL

STA-9090 (ganetespib) with Docetaxel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Emory University School of Medicine

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

9090-07

Identifier Type: -

Identifier Source: org_study_id