Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: STA-9090

• Registration Number: NCT00687934
• Lead Sponsor: Synta Pharmaceuticals Corp.

Brief Summary

An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-02
• Primary Completion: 2011-06
• Study Completion: 2011-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Patients must be documented to be refractory or not candidates for current approved therapies.
• Must have an ECOG status 0-2.
• Peripheral neuropathy < or = 2.
• Must have acceptable organ and marrow function per protocol parameters.
• No clinically significant ventricular arrythmias or ischemia.

Exclusion Criteria

• Must not be pregnant or breastfeeding.
• Chemotherapy or radiation within 3 weeks.
• Previous radiation to >25% of total bone marrow.
• Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation.
• Primary brain tumors or active brain metastases.
• Use of any investigational agents within 4 weeks.
• Treatment with chronic immunosuppressants.
• Uncontrolled, intercurrent illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ganetespib	STA-9090	Ganetespib once weekly infusion, dose escalation study, with treatment until progression

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities	Cycle 1

Trial Locations

Locations (2)

Premiere Oncology; 🇺🇸 Santa Monica, California, United States

US Oncology Dayton Oncology and Hematology, P.A; 🇺🇸 Kettering, Ohio, United States