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

NCT01039519 | Completed Phase 2 Results DMC

• 1 other identifier: 9090-05
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastrointestinal Stromal Tumor

Keywords

G.I. Stromal Tumor; GIST

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0

  Clinical benefit is defined as showing a complete response (CR), a partial response (PR) or stable disease (SD) for at least 16 weeks. * CR: disappearance of all target lesions and non-target lesions and no new lesions * PR: at least a 30% decrease in the sum of the longest diameter of target lesions, no disease progression for non-target lesions, and no new lesions * SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, no disease progression for non-target lesions, and no new lesions

  Week 16 up to Week 47

Secondary Outcomes (5)

• Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0

  Week 16 up to Week 47

• Kaplan-Meier Estimate of Progression Free Survival (PFS)

  Day 1 up to Week 47

• Kaplan-Meier Estimate of Overall Survival

  Day 1 up to week 97

• Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)

  Day 2 to Day 10

• Count of Participants With Treatment-Emergent Adverse Events (AEs)

  Day 1 up to Week 51

Study Arms (1)

ganetespib 200 mg/m^2

EXPERIMENTAL

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.

Drug: Ganetespib

Interventions

Ganetespib 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.

Also known as: STA-9090

ganetespib 200 mg/m^2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Synta Pharmaceuticals Corp.: lead

Study Sites (4)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Oregon Health and Science University-Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

STA 9090

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: VP Clinical Research
• Organization: Synta Pharmaceuticals

aoneill@syntapharma.com

781-541-7156

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 10, 2016
• Results First Posted: March 10, 2016

Record last verified: 2016-02

Locations

US (4)