NCT00293124

Brief Summary

The rationale is to assess the clinical and biological activity of Imatinib and to compare the data with historic data. Additionally this study has been designed to gain more experience with the treatment of GIST in several Central and Eastern European Countries.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2004

Typical duration for phase_3

Geographic Reach
9 countries

15 active sites

Status
completed

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 Start

First participant enrolled

March 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 13, 2015

Status Verified

May 1, 2012

Enrollment Period

2.3 years

First QC Date

February 16, 2006

Last Update Submit

August 11, 2015

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal TumorsGlivec

Outcome Measures

Primary Outcomes (1)

  • Time to Disease Progression

    until PD

Secondary Outcomes (2)

  • Time to Disease Progression

    until PD

  • Overall Survival

    until death

Interventions

GlivecDRUG

400mg p.o./day in a population of patients with locally advanced (=not amenable to surgery with curative intent) or metastatic malignant GIST. Glivec® may be increased to 600 mg p.o./day and then 800 mg p.o./day (400 mg b.i.d.) if the patient is progressing

Eligibility Criteria

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

You may qualify if:

  • Patients \>= 18 years of age
  • Histologically documented diagnosis of GIST which is malignant as well as unresectable (=not amenable to surgery with curative intent) and/or metastatic and therefore incurable Immunohistochemical documentation of c-kit (CD117) expression by tumor
  • At least one measurable site of disease (as defined by Southwestern Oncology Group Solid Tumor Response Criteria) which has not been previously embolised or irradiated
  • Performance status 0,1, 2 or 3 (ECOG)
  • Adequate end organ function, defined as the following: total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 2.5 x UNL (or \< 5 x ULN if hepatic metastases are present), creatinine \< 1.5 x ULN, ANC \> 1.5 x 109/L, platelets \> 100 x 109/L
  • Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
  • Life expectancy of at least 6 months
  • Written, voluntary, informed consent
  • Patients who were previously treated with chemotherapy will be eligible for this study
  • Patient who are at least 5 years free of melanoma will be eligible for this study

You may not qualify if:

  • Patient has received any other investigational agents within 28 days of first day of study drug dosing
  • Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention and CECOGs' approval is obtained, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
  • Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
  • Female patients who are pregnant or breast-feeding.
  • Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
  • Patient has a known brain metastasis
  • Patient has an acute or known chronic liver disease (i.e., chronic active hepatitis, cirrhosis)
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection
  • Patient received chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin-C) prior to study entry
  • Patient previously received radiotherapy to \>= 25 % of the bone marrow
  • Patient had a major surgery within 2 weeks prior to study entry
  • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
  • Therapeutic anticoagulation with warfarin (e.g. Coumadin® or Coumadine®)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

AKH, Universitätsklinik für Innere Medizin 1

Vienna, 1090, Austria

Location

Institute of Oncology Sarajevo

Sarajevo, Bosnia and Herzegovina

Location

SBALO National Oncology Center

Sofia, 1527, Bulgaria

Location

National Oncological Center Hospital

Sofia, Bulgaria

Location

Sofia Cancer Center compl. Mladost ,

Sofia, Bulgaria

Location

Clinical Hospital Split, Center of Oncology

Split, Croatia

Location

University Hospital Rebro

Zagreb, Croatia

Location

FN Bulovka

Prague, 186 00, Czechia

Location

Radioterapeticko-onkologicke. Oddeleni FN Motol

Prague, Czechia

Location

Lithuanian Oncology Center,

Vilnius, Lithuania

Location

Institutul Oncologic Bucuresti

Bucharest, Romania

Location

Institutul Oncologic Cluj

Cluj-Napoca, 400015, Romania

Location

Emergency Clinical County Hospital , Clin Oncol. Dep

Craiova, Romania

Location

Institut za onkologiju i

Belgrade, Serbia

Location

National Institute of Oncology

Bratislava, Slovakia

Location

Oncology Institute Ljubljana

Ljubljana, Slovenia

Location

Related Links

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Thomas Brodowicz, MD

    University Clinic of Internal Medicine I / Clinical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 17, 2006

Study Start

March 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2008

Last Updated

August 13, 2015

Record last verified: 2012-05

Locations

CZ(2)SL(1)BU(3)SE(1)LI(1)CR(2)AU(1)BO(1)RO(3)