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

Advanced Gastrointestinal Stromal Tumors Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940563
• Other study ID #: CSTI571BIT03
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2009
• Last updated: June 30, 2011
• Start date: March 2002

Study information

• Verified date: June 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA- Ufficio sperimentazioni cliniche
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00942279

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastrointestinal Stromal Tumors
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Imatinib

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response /RecIST criteria)		first 2 months monthly, then every 3 months	No
Secondary	SAE and tolerability profile		ongoing basis	Yes
Secondary	OS, DFS		12 months	No
Secondary	effects of the therapy when combined with other treatment modalities i.e. surgery of residual disease.		12 months	No
Secondary	which early predictive factors of tumor response may be of relevance, i.e. conventional pathologic characteristics of tumor and radiological aspects.		12 months	No