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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.
 
ClinicalTrials.gov Identifier: NCT00756509
Recruitment Status : Active, not recruiting
First Posted : September 22, 2008
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE September 19, 2008
First Posted Date  ICMJE September 22, 2008
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE August 29, 2008
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2008)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
  • objective tumor response rate based on RECIST criteria (complete response (CR) and partial response PR) [ Time Frame: 6 months ]
  • time to overall response (PR or CR) [ Time Frame: 6 months ]
  • duration of response [ Time Frame: 6 months ]
  • progression free survival (PFS) during the first 6 months using RECIST criteria [ Time Frame: 6 months ]
  • overall survival (OS) [ Time Frame: 6 months ]
  • safety and tolerability [ Time Frame: 6 months ]
  • population pharmacokinetics of Nilotinib [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2008)
  • objective tumor response rate based on RECIST criteria (complete response (CR) and partial response PR)
  • time to overall response (PR or CR)
  • duration of response
  • progression free survival (PFS) during the first 6 months using RECIST criteria
  • overall survival (OS)
  • safety and tolerability
  • population pharmacokinetics of Nilotinib
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Stromal Tumors
Intervention  ICMJE Drug: Nilotinib
800 mg/d orally
Study Arms  ICMJE Experimental: nilotinib
nilotinib
Intervention: Drug: Nilotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 8, 2019)
34
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2008)
40
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland,   France,   Germany,   Italy
Removed Location Countries Spain
 
Administrative Information
NCT Number  ICMJE NCT00756509
Other Study ID Numbers  ICMJE CAMN107DDE06
2008-000358-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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 www.clinicalstudydatarequest.com

URL: https://www.clinicalstudydatarequest.com
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP