NCT00265798

Brief Summary

This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate and sunitinib malate. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
11mo left

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Sep 2005Mar 2027

Study Start

First participant enrolled

September 14, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2010

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

January 21, 2014

Completed
13.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

April 28, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

December 14, 2005

Results QC Date

December 6, 2013

Last Update Submit

April 9, 2026

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    Objective response (complete response (CR)+ partial response (PR)) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of objective response.

    Up to 5 years

Secondary Outcomes (2)

  • Progression-free Survival

    Up to 5 years

  • Overall Survival

    Up to 5 years

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Sorafenib Tosylate

Interventions

Sorafenib TosylateDRUG
Also known as: BAY 43-9006 Tosylate, BAY 54 9085, BAY 54-9085, BAY 549085, BAY-54-9085, BAY549085, Nexavar, sorafenib
Treatment (sorafenib tosylate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed gastrointestinal stromal tumor
  • Not amenable to curative surgery
  • Kit-expressing tumor
  • Disease progression (i.e., new lesion or 20% increase in unidimensional tumor size) on or after treatment with imatinib mesylate and sunitinib malate
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
  • Only site of measurable disease must be outside of previously irradiated area
  • No known brain metastases
  • Performance status - ECOG 0-2
  • More than 3 months
  • Absolute neutrophil count \> 1,500/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Bilirubin normal
  • AST and ALT \< 2.5 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance \> 60 mL/min
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62702, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Dr. Hedy L. Kindler
Organization
University of Chicago
hkindler@medicine.bsd.uchicago.edu
773-702-0360

Study Officials

  • Hedy L Kindler

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Study Start

September 14, 2005

Primary Completion

February 11, 2010

Study Completion (Estimated)

March 31, 2027

Last Updated

April 28, 2026

Results First Posted

January 21, 2014

Record last verified: 2026-02

Locations

US(6)