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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940563
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : July 1, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Advanced Gastrointestinal Stromal Tumors Drug: Imatinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STI571 (Imatinib) in KIT-expressing Gastrointestinal Stromal Tumors (GIST): a Prospective, Open-label, Multicenter Study on Best Clinical Use in the Advanced Disease.
Study Start Date : March 2002
Actual Primary Completion Date : August 2004

Arm Intervention/treatment
Experimental: Imatinib Drug: Imatinib

Primary Outcome Measures :
  1. tumor response /RecIST criteria) [ Time Frame: first 2 months monthly, then every 3 months ]

Secondary Outcome Measures :
  1. SAE and tolerability profile [ Time Frame: ongoing basis ]
  2. OS, DFS [ Time Frame: 12 months ]
  3. effects of the therapy when combined with other treatment modalities i.e. surgery of residual disease. [ Time Frame: 12 months ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00940563

Novartis Investigative Site
Ancona, Italy
Novartis Investigative Site
Aviano, Italy
Novartis Investigative Site
Bari, Italy
Novartis Investigative Site
Bergamo, Italy
Novartis Investigative Site
Bologna, Italy
Novartis Investigative Site
Candiolo, Italy
Novartis Investigative Site
Ferrara, Italy
Novartis Investigative Site
Firenze, Italy
Novartis Investigative Site
Genova, Italy
Novartis Investigative Site
Livorno, Italy
Novartis Investigative Site
Meldola, Italy
Novartis Investigative Site
Messina, Italy
Novartis Investigative Site
Milano, Italy
Novartis Investigative Site
Monserrato, Italy
Novartis Investigative Site
Napoli, Italy
Novartis Investigative Site
Nola, Italy
Novartis Investigative Site
Padova, Italy
Novartis Investigative Site
Palermo, Italy
Novartis Investigative Site
Perugia, Italy
Novartis Investigative Site
Pisa, Italy
Novartis Investigative Site
Ravenna, Italy
Novartis Investigative Site
Roma, Italy
Novartis Investigative Site
Rozzano, Italy
Novartis Investigative Site
Sassari, Italy
Novartis Investigative Site
Torino, Italy
Novartis Investigative Site
Verona, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00940563     History of Changes
Obsolete Identifiers: NCT00942279
Other Study ID Numbers: CSTI571BIT03
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2011

Keywords provided by Novartis:
advanced GIST

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action