NCT00940563

Brief Summary

Open-label, multicenter study of imatinib (400mg/die p.o.)in patients with advanced gastrointestinal stromal tumors. Patients will be treated for up to 12 months. Data regarding its best clinical use in terms of tumor response, survival, tolerability and safety profile will be prospectively collected.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

26 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, 2002

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

2.4 years

First QC Date

June 26, 2009

Last Update Submit

June 30, 2011

Conditions

Advanced Gastrointestinal Stromal Tumors

Keywords

GISTimatinibadvanced GIST

Outcome Measures

Primary Outcomes (1)

  • tumor response /RecIST criteria)

    first 2 months monthly, then every 3 months

Secondary Outcomes (4)

  • SAE and tolerability profile

    ongoing basis

  • OS, DFS

    12 months

  • effects of the therapy when combined with other treatment modalities i.e. surgery of residual disease.

    12 months

  • which early predictive factors of tumor response may be of relevance, i.e. conventional pathologic characteristics of tumor and radiological aspects.

    12 months

Study Arms (1)

Imatinib

EXPERIMENTAL
Drug: Imatinib

Interventions

ImatinibDRUG
Imatinib

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, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
  • Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
  • At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
  • Performance status 0,1, 2 or 3 (ECOG).
  • Adequate end organ function.
  • Adequate bone marrow function.
  • Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.

You may not qualify if:

  • Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
  • Other primary malignancy with \< 5 years clinically assessed disease free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged after consultation with the Steering committee to entail a low risk of relapse.
  • Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
  • Pregnancy, breast-feeding.
  • Severe and/or uncontrolled medical disease.
  • Known brain metastasis.
  • Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  • Known diagnosis of human immunodeficiency virus (HIV) infection.
  • Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
  • Previous radiotherapy to ≥ 25 % of the bone marrow.
  • Major surgery within 2 weeks prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Novartis Investigative Site

Ancona, Italy

Location

Novartis Investigative Site

Aviano, Italy

Location

Novartis Investigative Site

Bari, Italy

Location

Novartis Investigative Site

Bergamo, Italy

Location

Novartis Investigative Site

Bologna, Italy

Location

Novartis Investigative Site

Candiolo, Italy

Location

Novartis Investigative Site

Ferrara, Italy

Location

Novartis Investigative Site

Florence, Italy

Location

Novartis Investigative Site

Genova, Italy

Location

Novartis Investigative Site

Livorno, Italy

Location

Novartis Investigative Site

Meldola, Italy

Location

Novartis Investigative Site

Messina, Italy

Location

Novartis Investigative Site

Milan, Italy

Location

Novartis Investigative Site

Monserrato, Italy

Location

Novartis Investigative Site

Napoli, Italy

Location

Novartis Investigative Site

Nola, Italy

Location

Novartis Investigative Site

Padua, Italy

Location

Novartis Investigative Site

Palermo, Italy

Location

Novartis Investigative Site

Perugia, Italy

Location

Novartis Investigative Site

Pisa, Italy

Location

Novartis Investigative Site

Ravenna, Italy

Location

Novartis Investigative Site

Roma, Italy

Location

Novartis Investigative Site

Rozzano, Italy

Location

Novartis Investigative Site

Sassari, Italy

Location

Novartis Investigative Site

Torino, Italy

Location

Novartis Investigative Site

Verona, Italy

Location

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2009

First Posted

July 16, 2009

Study Start

March 1, 2002

Primary Completion

August 1, 2004

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

IT(26)