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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 16, 2011
Last updated: October 18, 2015
Last verified: October 2015
This study will evaluate the preliminary efficacy of nilotinib in pretreated patients (Imatinib, Sunitinib) with unresectable or metastatic gastrointestinal stromal tumors.

Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: Nilotinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Stable disease (SD) [ Time Frame: During the first 4 months ] [ Designated as safety issue: No ]
  • Partial response (PR) [ Time Frame: during the first 4 months ] [ Designated as safety issue: No ]
  • Complete response (CR) [ Time Frame: during the first 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to response ( SD, PR, CR) [ Time Frame: during the first 4 months ] [ Designated as safety issue: No ]
  • Time to tumor progression [ Time Frame: during the first 4 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: during 12 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: during 12 months ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) of the patients who were included due to an intolerability of a prior treatment. [ Time Frame: during 12 months ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: November 2008
Study Completion Date: August 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nilotinib Drug: Nilotinib
Other Name: AMN107


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01289028

Novartis Investigative Site
Bad Saarow, Germany, 155226
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Duesseldorf, Germany, 40479
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Frankfurt, Germany, 60488
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Halle/'Saale, Germany, 06120
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Mannheim, Germany, 68167
Novartis Investigative Site
Muenchen, Germany, 81377
Novartis Investigative Site
Muenchen, Germany, 81675
Novartis Investigative Site
Ulm, Germany, 89081
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Genova, GE, Italy, 16132
Novartis Investigative Site
Taormina, ME, Italy, 98039
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
Padova, PD, Italy, 35100
Novartis Investigative Site
Aviano, PN, Italy, 33081
Novartis Investigative Site
Torino, TO, Italy, 10153
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01289028     History of Changes
Other Study ID Numbers: CAMN107DDE05  2008-000357-35 
Study First Received: January 16, 2011
Last Updated: October 18, 2015
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on October 21, 2016