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
  Purpose

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 Intervention Phase
Advanced Gastrointestinal Stromal Tumors
Drug: Imatinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • tumor response /RecIST criteria) [ Time Frame: first 2 months monthly, then every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 135
Study Start Date: March 2002
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imatinib Drug: Imatinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940563

Locations
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, Italy
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00940563     History of Changes
Obsolete Identifiers: NCT00942279
Other Study ID Numbers: CSTI571BIT03
Study First Received: June 26, 2009
Last Updated: June 30, 2011
Health Authority: Italy: AIFA- Ufficio sperimentazioni cliniche

Keywords provided by Novartis:
GIST
imatinib
advanced GIST

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014