Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Gastrointestinal Stromal Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718562
• Other study ID #: CAMN107D1201
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2008
• Last updated: February 20, 2017
• Start date: September 2008
• Est. completion date: July 2013

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• AMN107

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Niigata-city	Niigata
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Suita-city	Osaka
Japan	Novartis Investigative Site	Sunto-gun	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib		24 weeks
Secondary	DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR)		24 weeks
Secondary	Safety		24 weeks
Secondary	PK profile		24 weeks

External Links

•   Results for CAMN107D1201 from the Novartis Clinical Trials website