A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)

A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)

Gastrointestinal Stromal Tumor

Completed

2

Start Date 01/01/2010

Age of Trial (yrs) 14.9

Gleevec-resistant

HSP90 inhibitor

Destroy KIT

Specifically GIST and only GIST

9090-05

Synta Pharmaceuticals Corp.

Robert Bradley 781-541-7984 rbradley@syntapharma.com

Intravenous

Has results published at ClinicalTrials.gov

A Non-randomized, Open Label, Multi-center Phase 2 Study Evaluating the Efficacy and Safety of STA-9090 in Patients With Metastatic and/or Unresectable GIST Resistant or Refractory to Prior Systemic Treatments Including Imatinib and Sunitinib

Criteria

Inclusion Criteria:

* Must be at least 18 years of age at the time of study entry
* Must have histologically confirmed metastatic and/or unresectable GIST
* Must have measurable disease on CT or MRI as defined by RECIST
* Must have documented failure (due to either progression or intolerance)of at least prior imatinib and sunitinib. Previous administration of other known heat shock protein 90 (Hsp90) inhibitors is permitted
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Must have acceptable laboratory values as defined in the protocol

Exclusion Criteria:

* Known CNS metastases
* Major surgery within 4 weeks prior to receiving STA-9090
* Use of any investigational agents within 2 weeks or 6 half-lives of the agent, whichever is shorter prior to receiving STA-9090
* No treatment with chronic immunosuppressants
* Must have otherwise adequate health status as defined in the protocol
* Left ventricular ejection fraction (LVEF) < than or = 50% at baseline
* Baseline QTc > 470 msec
* Pregnant or lactating females