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

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor Malignancies
• Intervention / Treatment: Drug: STA-9090 (ganetespib) with Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics	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).	June 2011

Collaborators and Investigators

• Sponsor: Synta Pharmaceuticals Corp.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 11, 2010
• First Submitted That Met QC Criteria: August 16, 2010
• First Posted (Estimate): August 17, 2010

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: cancer; tumor; solid tumor malignancies; HSP90 inhibitor; STA-9090; ganetespib
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: 9090-07