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Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00756509
Recruitment Status : Active, not recruiting
First Posted : September 22, 2008
Last Update Posted : March 20, 2024
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: Nilotinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment
Actual Study Start Date : August 29, 2008
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: nilotinib
Drug: Nilotinib
800 mg/d orally

Primary Outcome Measures :
  1. To evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors. Efficacy is defined as the proportion of patients showing stable disease (SD), partial response (PR) or complete response (CR) during the [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. objective tumor response rate based on RECIST criteria (complete response (CR) and partial response PR) [ Time Frame: 6 months ]
  2. time to overall response (PR or CR) [ Time Frame: 6 months ]
  3. duration of response [ Time Frame: 6 months ]
  4. progression free survival (PFS) during the first 6 months using RECIST criteria [ Time Frame: 6 months ]
  5. overall survival (OS) [ Time Frame: 6 months ]
  6. safety and tolerability [ Time Frame: 6 months ]
  7. population pharmacokinetics of Nilotinib [ Time Frame: 6 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years
  • Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic and therefore not amenable to surgery or combined modality with curative intent prior to or at Visit 1
  • At least one measurable site of disease on CT/MRI scan at Visit 1, as defined by RECIST criteria (see Post Text Suppl 3 for details) The scans should be at maximum 2 weeks old. New scans are only required as baseline scans if they are older then approx. 2 weeks.
  • WHO Performance Status of 0, 1 or 2
  • Patients must have the following laboratory values (≥ LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):

    1. Potassium ≥ LLN,
    2. Magnesium ≥ LLN,
    3. Phosphorus ≥ LLN,
    4. Total calcium (corrected for serum albumin) ≥ LLN
  • Patients must have normal organ, electrolyte, and marrow function as defined below:

    1. Absolute Neutrophil Count (ANC) ≥ 1.5x 109/L;
    2. Platelets ≥ 100 x 109/L;
    3. ALT and AST ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if considered due to tumor;
    4. Alkaline phosphatase ≤ 2.5 x ULN unless considered due to tumor;
    5. Serum bilirubin ≤ 1.5 x ULN;
    6. Serum lipase and amylase ≤ 1.5 x ULN;
    7. Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min. (calculated creatinine clearance using Cockroft formula is acceptable)
  • Ability to understand and willingness to sign a written informed consent

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 with the exception of imatinib targeted therapy as an adjuvant therapy
  • 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 including any one of the following:

    1. LVEF < 45% or below the institutional LLN range (whichever is higher) as determined by echocardiogram at Visit 1
    2. Complete left bundle branch block
    3. Use of a ventricular paced cardiac pacemaker
    4. Congenital long QT syndrome or family history of long QT syndrome
    5. History of or presence of significant ventricular or atrial tachyarrhythmias
    6. Clinically significant resting bradycardia (< 50 beats per minute)
    7. QTc > 450 msec on screening ECG (using the QTcF formula). If QTc > 450 msec and electrolytes are not within normal ranges (electrolytes should be corrected and then the patient rescreened for QTc.
    8. Right bundle branch block plus left anterior hemiblock, bifascicular block
    9. Myocardial infarction within 12 months prior to Visit 1
    10. Other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension,)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00756509

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Novartis Investigative Site
HUS, Finland, FIN-00029
Novartis Investigative Site
Lyon, France, 69373
Novartis Investigative Site
Bad Saarow, Germany, 15526
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Muenchen, Germany, 81377
Novartis Investigative Site
Milano, MI, Italy, 20133
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00756509    
Other Study ID Numbers: CAMN107DDE06
2008-000358-11 ( EudraCT Number )
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
unresectable or metastatic GIST
1st. line treatment
Additional relevant MeSH terms:
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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
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action