Clinical trial NCT00718562: Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib
Official title: A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumors
Keywords: nilotinib
AMN107
Sunitinib
Sunitinib malate
Imatinib
Imatinib mesylate
Tyrosine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 35
Sex: ALL
Minimum age (years): 20
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 efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.


Eligibility criteria: Inclusion Criteria:

* Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
* At least one measurable site of disease on CT/MRI scan
* PS≤2
* Normal organ, electrolyte, and bone marrow function

Exclusion Criteria:

* Previous treatment with nilotinib or any other drug in this class or other targeted therapy
* Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
* Impaired cardiac function
* Use of coumarin derivatives (i.e. warfarin)
* Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib
timeFrame: 24 weeks
Secondary outcomes:
measure: DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR)
timeFrame: 24 weeks
measure: Safety
timeFrame: 24 weeks
measure: PK profile
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Niigata-city
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sunto-gun
country: Japan
facility: Novartis Investigative Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Sawaki A, Nishida T, Doi T, Yamada Y, Komatsu Y, Kanda T, Kakeji Y, Onozawa Y, Yamasaki M, Ohtsu A. Phase 2 study of nilotinib as third-line therapy for patients with gastrointestinal stromal tumor. Cancer. 2011 Oct 15;117(20):4633-41. doi: 10.1002/cncr.26120. Epub 2011 Mar 31.