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A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00940563
First received: June 26, 2009
Last updated: June 30, 2011
Last verified: June 2011

June 26, 2009
June 30, 2011
March 2002
August 2004   (final data collection date for primary outcome measure)
tumor response /RecIST criteria) [ Time Frame: first 2 months monthly, then every 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940563 on ClinicalTrials.gov Archive Site
  • SAE and tolerability profile [ Time Frame: ongoing basis ] [ Designated as safety issue: Yes ]
  • OS, DFS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • effects of the therapy when combined with other treatment modalities i.e. surgery of residual disease. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • which early predictive factors of tumor response may be of relevance, i.e. conventional pathologic characteristics of tumor and radiological aspects. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Prospective, Multicenter Study on Best Clinical Use of Imatinib in the Advanced Gastrointestinal Stromal Tumors
STI571 (Imatinib) in KIT-expressing Gastrointestinal Stromal Tumors (GIST): a Prospective, Open-label, Multicenter Study on Best Clinical Use in the Advanced Disease.

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Gastrointestinal Stromal Tumors
Drug: Imatinib
Experimental: Imatinib
Intervention: Drug: Imatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
Not Provided
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients ≥ 18 years of age.
  2. Histologically documented diagnosis of GIST, unresectable and/or metastatic and therefore incurable with any conventional multimodality approach.
  3. Immunohistochemical documentation of c-kit (CD117) expression by tumor, as detected on a tumor sample taken within 6 weeks of study entry.
  4. At least one measurable site of disease (RECIST Criteria), or other response assessment criteria, as appropriate.
  5. Performance status 0,1, 2 or 3 (ECOG).
  6. Adequate end organ function.
  7. Adequate bone marrow function.
  8. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.

Exclusion Criteria:

  1. Previous treatment with any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
  2. 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.
  3. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
  4. Pregnancy, breast-feeding.
  5. Severe and/or uncontrolled medical disease.
  6. Known brain metastasis.
  7. Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  8. Known diagnosis of human immunodeficiency virus (HIV) infection.
  9. Previous treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin-C).
  10. Previous radiotherapy to ≥ 25 % of the bone marrow.
  11. Major surgery within 2 weeks prior to study entry.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00940563
CSTI571BIT03
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP