Clinical trial NCT01289028: Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST
Imatinib
Sunitinib
Gastrointestinal
Stromal
Tumors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percent of Patients Achieving Stable Disease (SD)
timeFrame: During the first 4 months
measure: Percent of Patients Achieving Partial Response (PR)
timeFrame: during the first 4 months
measure: Percent of Patients Achieving Complete Response (CR)
timeFrame: during the first 4 months
Secondary outcomes:
measure: Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population
timeFrame: 24 weeks and 52 weeks
measure: Time to Overall Response (CR or PR): Per Protocol Population
timeFrame: 24 weeks and 52 weeks
measure: Time to Tumor Progression
timeFrame: during the first 4 months
measure: Duration of Overall Response
timeFrame: during 12 months
measure: Overall Survival, Number of Events Related to Progression of the Disease
timeFrame: during 12 months
measure: Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment.
timeFrame: during 12 months
Other outcomes:
Locations:
city: Bad Saarow
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Halle/'Saale
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Taormina
country: Italy
facility: Novartis Investigative Site
state: ME
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Aviano
country: Italy
facility: Novartis Investigative Site
state: PN
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: