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.

Study Overview

• Status: Completed
• Conditions: Advanced Gastrointestinal Stromal Tumors
• Intervention / Treatment: Drug: Imatinib

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • 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
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imatinib	Drug: Imatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
tumor response /RecIST criteria)	first 2 months monthly, then every 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Primary Completion (Actual): August 1, 2004

Study Registration Dates

• First Submitted: June 26, 2009
• First Submitted That Met QC Criteria: July 15, 2009
• First Posted (Estimate): July 16, 2009

Study Record Updates

• Last Update Posted (Estimate): July 1, 2011
• Last Update Submitted That Met QC Criteria: June 30, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: GIST; imatinib; advanced GIST
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: CSTI571BIT03