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

This study is currently recruiting participants.

Verified May 2011 by Synta Pharmaceuticals Corp.

First Received on December 23, 2009. Last Updated on May 23, 2011 History of Changes

Sponsor:	Synta Pharmaceuticals Corp.
Information provided by:	Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:	NCT01039519

Purpose

The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumor	Drug: STA-9090 (ganetespib)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Synta Pharmaceuticals Corp.:

Primary Outcome Measures:

Assessment of Clinical Benefit Rate [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of the Objective Response Rate [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Assessment of Progression-Free Survival [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Assessment of Overall Survival [ Time Frame: 22 months ] [ Designated as safety issue: No ]
Assessment of safety and tolerability by adverse events rate and laboratory evaluations [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	55
Study Start Date:	December 2009
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Intervention Details:

STA-9090 (ganetespib) IV infusion once weekly for 3 consecutive weeks followed by one week dose free interval

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039519

Contacts

Contact: Robert Bradley

781-541-7984

Locations

United States, California
UCLA Medical Center	Recruiting
Los Angeles, California, United States, 90095
Contact: Bartosz Chmielowski, MD 310-206-3669 BChmielowski@mednet.ucla.edu
Principal Investigator: Bartosz Chmielowski, MD
United States, Massachusetts
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Tarsha Huftalen, Rn 617-632-5117 tmhuftalen@partners.org
Principal Investigator: George Demetri, MD
United States, Oregon
Oregon Health and Science University-Knight Cancer Institute	Recruiting
Portland, Oregon, United States, 97239
Contact: Daniel Hansen, BS 503-418-1815 hansedan@ohsu.edu
Principal Investigator: Michael C Heinrich, MD
United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Monica Davey, RN BSN MEd MBA 215-728-5534 M_Davey@fccc.edu
Principal Investigator: Margaret von Mehren, MD

Sponsors and Collaborators

Synta Pharmaceuticals Corp.

More Information

No publications provided

Responsible Party:	Robert Bradley, Synta Pharmaceuticals Corp.
ClinicalTrials.gov Identifier:	NCT01039519 History of Changes
Other Study ID Numbers:	9090-05
Study First Received:	December 23, 2009
Last Updated:	May 23, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Synta Pharmaceuticals Corp.:

G.I. Stromal Tumor
GIST

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012