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Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator

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: NCT01742299
Recruitment Status : Active, not recruiting
First Posted : December 5, 2012
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to allow continued use of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.

Condition or disease Intervention/treatment Phase
GIST and CML Drug: imatinib mesylate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Multi-center Imatinib Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Imatinib Study and Are Judged by the Investigator to Benefit From Continued Imatinib Treatment
Actual Study Start Date : March 26, 2013
Estimated Primary Completion Date : April 21, 2033
Estimated Study Completion Date : April 21, 2033

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: imatinib mesylate
The starting dose of imatinib should be the same as the last dose that was given in the parent imatinib study (400 mg/day to 600 mg/day). After this, the dose of imatinib is based on the investigator's judgment.
Drug: imatinib mesylate
Imatinib will be provided as 100 mg and 400 mg tablets taken orally once daily unless other wise instructed by investigator
Other Name: STI571




Primary Outcome Measures :
  1. To evaluate long term safety data (SAEs and AEs) [ Time Frame: Until no patients are left on study, with an expected average of 20 years ]
    To better characterize the long-term safety of imatinib in patients who are on imatinib treatment and are benefiting from the treatment as judged by the investigator


Secondary Outcome Measures :
  1. To evaluate clinical benefit as assessed by the investigator. [ Time Frame: Until no patients are left on study, with an expected average of 20 years ]
    To better characterize the long-term safety of imatinib in patients who are on imatinib treatment and are benefiting from the treatment as judged by the investigator



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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving imatinib and has fulfilled all their requirements in the parent study. 2.Patient is currently benefiting from the treatment with imatinib, as determined by the investigator. 3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. 5. Written informed consent obtained prior to enrolling in roll-over study. 6.If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.

    Exclusion Criteria:

    • 1. Patient has been permanently discontinued from imatinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
  2. Patient has participated in a Novartis sponsored combination trial where imatinib was dispensed in combination with another study medication and patient is still receiving combination therapy.
  3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test.
  4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of imatinib. Male patients must use highly effective contraception during the study and for 30 days after the final dose of imatinib.

Highly effective contraception is defined as either:

  • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
  • Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
  • Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.

In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.

Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.

If a study patient becomes pregnant or suspects they are pregnant during the study or within 30 days of the final dose of imatinib, the Investigator/Study Doctor needs to be informed immediately and ongoing study treatment with imatinib has to be stopped immediately.


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 ClinicalTrials.gov identifier (NCT number): NCT01742299


Locations
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United States, California
University of California at Los Angeles UCLA
Los Angeles, California, United States, 90095
United States, Illinois
Lurie Children's Hospital of Chicago Clinical Research Office
Chicago, Illinois, United States, 60611
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Dept of Onc
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute SC (2)
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute Oncology Department
Detroit, Michigan, United States, 48201
United States, New York
Weill Cornell Medical Center Dept. of Oncology
New York, New York, United States, 10021
United States, Oregon
Oregon Health and Science University Dept of Oncology
Portland, Oregon, United States, 97239
United States, Pennsylvania
Fox Chase Cancer Center Dept.ofFoxChaseCancerCtr.
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
University of Texas MD Anderson Cancer Center UT MD Anderson
Houston, Texas, United States, 77030
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100730
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210002
China
Novartis Investigative Site
Beijing, China, 100036
Novartis Investigative Site
Guangzhou, China, 510060
Novartis Investigative Site
Shanghai, China, 200433
Finland
Novartis Investigative Site
HUS, Finland, FIN-00029
France
Novartis Investigative Site
Lille, France, 59037
Novartis Investigative Site
Pessac, France, 33604
Novartis Investigative Site
Poitiers, France, 86000
Hong Kong
Novartis Investigative Site
Hong Kong SAR, Hong Kong
Romania
Novartis Investigative Site
Bucharest, Romania, 022328
Novartis Investigative Site
Cluj-Napoca, Romania, 400124
Singapore
Novartis Investigative Site
Singapore, Singapore, 119228
Novartis Investigative Site
Singapore, Singapore, 169608
Novartis Investigative Site
Singapore, Singapore, 169610
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4031
Thailand
Novartis Investigative Site
Bangkok, Thailand, 10700
Turkey
Novartis Investigative Site
Ankara, Turkey, 06100
United Kingdom
Novartis Investigative Site
Withington, Greater Manchester, United Kingdom, M20 4BX
Novartis Investigative Site
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01742299    
Other Study ID Numbers: CSTI571A2406
2012-002540-25 ( EudraCT Number )
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
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 www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Glivec/Gleevec
CML
GIST
Imatinib mesylate
Additional relevant MeSH terms:
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Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action