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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumor

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of Clinical Benefit Rate

Outcome Time Frame:

15 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

9090-05

NCT ID:

NCT01039519

Start Date:

December 2009

Completion Date:

September 2012

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • G.I. Stromal Tumor
  • GIST
  • Gastrointestinal Stromal Tumors

Name

Location

Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
UCLA Medical Center Los Angeles, California  90095-7059
Dana Farber Cancer Institute Boston, Massachusetts  02115
Oregon Health and Science University-Knight Cancer Institute Portland, Oregon  97239