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

NCT01183364 | Completed Phase 1

• 1 other identifier: 9090-07
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

solid tumor malignancies; tumor; cancer; STA-9090; ganetespib; HSP90 inhibitor

Outcome Measures

Primary Outcomes (1)

• Safety of STA-9090 (ganetespib) and docetaxel combination

  The number of adverse events will be used as a measure of safety

  June 2011

Secondary Outcomes (1)

• Pharmacokinetics

  June 2011

Study Arms (1)

STA-9090 and Docetaxel

EXPERIMENTAL

STA-9090 (ganetespib) and Docetaxel

Drug: STA-9090 (ganetespib) with Docetaxel

Interventions

STA-9090 (ganetespib) with Docetaxel 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.

STA-9090 and Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (1)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

STA 9090

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 17, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

US (1)