Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

An Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289028
• Other study ID #: CAMN107DDE05
• Secondary ID: 2008-000357-35
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2011
• Last updated: October 18, 2015
• Start date: November 2008
• Est. completion date: August 2014

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent.

• Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included.)

• At least one measurable site of disease on CT/MRI as defined by RECIST criteria.

Exclusion Criteria:

• Prior treatment with nilotinib.

• Treatment with any cytotoxic and/or investigational cytotoxic drug = 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1.

• Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.

• Impaired cardiac function at visit 1

• Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Nilotinib

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Bad Saarow
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Halle/'Saale
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Ulm
Italy	Novartis Investigative Site	Aviano	PN
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Padova	PD
Italy	Novartis Investigative Site	Taormina	ME
Italy	Novartis Investigative Site	Torino	TO

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stable disease (SD)		During the first 4 months	No
Primary	Partial response (PR)		during the first 4 months	No
Primary	Complete response (CR)		during the first 4 months	No
Secondary	The time to response ( SD, PR, CR)		during the first 4 months	No
Secondary	Time to tumor progression		during the first 4 months	No
Secondary	Duration of response		during 12 months	No
Secondary	Overall survival		during 12 months	No
Secondary	Progression free survival (PFS) of the patients who were included due to an intolerability of a prior treatment.		during 12 months	No

External Links

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