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

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

ClinicalTrials.gov Identifier: NCT01742299

Novartis Reference Number: CSTI571A2406

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
GIST and CML
Phase 
Phase 4
Overall status 
Active, not recruiting
Enrollment count 
155 participants
Start date 
Mar 26, 2013
Completion date 
Apr 21, 2033
Gender 
All
Age(s)
(Child, Adult, Older Adult)

Interventions

Drug
imatinib mesylate
Imatinib will be provided as 100 mg and 400 mg tablets taken orally once daily unless other wise instructed by investigator

Eligibility Criteria

Inclusion Criteria:

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.
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.
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.
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.

Study Locations

United States
University of California at Los Angeles UCLA
-
Los Angeles, 90095
California
United States
Lurie Children's Hospital of Chicago Clinical Research Office
-
Chicago, 60611
Illinois
United States
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Dept of Onc
-
Baltimore, 21231
Maryland
United States
Dana Farber Cancer Institute SC (2)
-
Boston, 02215
Massachusetts
United States
Karmanos Cancer Institute Oncology Department
-
Detroit, 48201
Michigan
United States
Weill Cornell Medical Center Dept. of Oncology
-
New York, 10021
New York
United States
Oregon Health and Science University Dept of Oncology
-
Portland, 97239
Oregon
United States
Fox Chase Cancer Center Dept.ofFoxChaseCancerCtr.
-
Philadelphia, 19111
Pennsylvania
United States
University of Texas MD Anderson Cancer Center UT MD Anderson
-
Houston, 77030
Texas
United States
China
Novartis Investigative Site
-
Beijing, 100730
Beijing
China
Novartis Investigative Site
-
Nanjing, 210002
Jiangsu
China
Novartis Investigative Site
-
Beijing, 100036
-
China
Novartis Investigative Site
-
Guangzhou, 510060
-
China
Novartis Investigative Site
-
Shanghai, 200433
-
China
Finland
Novartis Investigative Site
-
HUS, FIN-00029
-
Finland
France
Novartis Investigative Site
-
Lille, 59037
-
France
Novartis Investigative Site
-
Pessac, 33604
-
France
Novartis Investigative Site
-
Poitiers, 86000
-
France
Hong Kong
Novartis Investigative Site
-
Hong Kong SAR,
-
Hong Kong
Romania
Novartis Investigative Site
-
Bucharest, 022328
-
Romania
Novartis Investigative Site
-
Cluj-Napoca, 400124
-
Romania
Singapore
Novartis Investigative Site
-
Singapore, 119228
-
Singapore
Novartis Investigative Site
-
Singapore, 169608
-
Singapore
Novartis Investigative Site
-
Singapore, 169610
-
Singapore
Switzerland
Novartis Investigative Site
-
Basel, 4031
-
Switzerland
Thailand
Novartis Investigative Site
-
Bangkok, 10700
-
Thailand
Turkey
Novartis Investigative Site
-
Ankara, 06100
-
Turkey
United Kingdom
Novartis Investigative Site
-
Withington, M20 4BX
Greater Manchester
United Kingdom
Novartis Investigative Site
-
Sutton, SM2 5PT
Surrey
United Kingdom

Have a question?

Call 1-999-669-6682 or email [email protected]