Clinical trial NCT01039519: A Study Evaluating STA-9090 in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumor
Keywords: G.I. Stromal Tumor
GIST
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2009-12-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants Showing Clinical Benefit Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0
timeFrame: Week 16 up to Week 47
Secondary outcomes:
measure: Percentage of Participants Showing an Objective Response Based on RECIST Version 1.0
timeFrame: Week 16 up to Week 47
measure: Kaplan-Meier Estimate of Progression Free Survival (PFS)
timeFrame: Day 1 up to Week 47
measure: Kaplan-Meier Estimate of Overall Survival
timeFrame: Day 1 up to week 97
measure: Percentage of Participants Showing a Tumor Response During Cycle 1 in Selected Participants Measured by Positron Emission Tomography (PET)
timeFrame: Day 2 to Day 10
measure: Count of Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: Day 1 up to Week 51
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health and Science University-Knight Cancer Institute
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: