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

Phase 2

Completed

• Conditions: Advanced Gastrointestinal Stromal Tumors
• Interventions: Drug: Imatinib

• Registration Number: NCT00940563
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2004-08
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib	Imatinib	-

Primary Outcome Measures

Name	Time	Method
tumor response /RecIST criteria)	first 2 months monthly, then every 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Verona, Italy