Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)

Gastrointestinal Stromal Tumors Clinical Trial

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Official title:

Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01483014
• Other study ID #: CSTI571BBR10
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2011
• Last updated: November 16, 2016
• Start date: June 2008
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients with age between 18 and 80 years

• diagnosis of GIST not previously treated

• Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function)

Exclusion criteria:

• presence of metastatic disease

• use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• imatinib mesylate

Locations

Country	Name	City	State
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investivative site	Belo Horizonte
Brazil	Novartis Investigative Site	Florianopolis	SC
Brazil	Novartis Investivative site	Florianopolis
Brazil	Novartis Investivative site	Porto Alegre
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investivative site	Rio de Janeiro
Brazil	Novartis Investivative site	Sao Paulo
Brazil	Novartis Investigative Site	São Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP
Brazil	Novartis Investigative Site	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response using the RECIST criteria		16 weeks	No
Secondary	Progression free survival		16 weeks	No
Secondary	Time and duration of response		16 weeks	No
Secondary	Time to treatment failure		16 weeks	No
Secondary	Overall survival		16 weeks	No

External Links

•   Publication ISSN 0732183X
•   Results for CSTI571BBR10 from the Novartis Clinical Trials website