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

NCT ID: NCT01039519

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

Brief Summary

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

Detailed Description

Planned:

• Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment.
• Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results.

Analyzed:

• Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.

Conditions

Gastrointestinal Stromal Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ganetespib 200 mg/m^2

Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Ganetespib

Intervention Type: DRUG

Ganetespib 200 mg/m\^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week. Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.

Interventions

Ganetespib

Ganetespib 200 mg/m\^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week. Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

STA-9090

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 computed tomography or magnetic resonance imaging as defined by Response Evaluation Criteria in Solid Tumors (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 central nervous system 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 corrected QT interval (QTc) > 470 msec
• Pregnant or lactating females

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synta Pharmaceuticals Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UCLA Medical Center

Los Angeles, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Oregon Health and Science University-Knight Cancer Institute

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

9090-05

Identifier Type: -

Identifier Source: org_study_id