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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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: GIST and CML

Intervention: STI571 (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals


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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of patients receiving imatinib

Secondary outcome: Frequency and nature of serious adverse events


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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. 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 a combination of any two of the following (a+b or a+c, or b+c):

1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository 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 (e. g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to enrolling. 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 being pregnant during the study or within 30 days after the final dose of imatinib, the investigator needs to be informed immediately and ongoing study treatment with imatinib has to be stopped

Locations and Contacts

Novartis Investigative Site, Beijing 100036, China

Novartis Investigative Site, Guangzhou 510060, China

Novartis Investigative Site, Shanghai 200433, China

Novartis Investigative Site, HUS FIN-00029, Finland

Novartis Investigative Site, Lille 59037, France

Novartis Investigative Site, Pessac 33604, France

Novartis Investigative Site, Poitiers 86021, France

Novartis Investigative Site, Hong Kong SAR, Hong Kong

Novartis Investigative Site, Cluj-Napoca 400015, Romania

Novartis Investigative Site, Singapore 119228, Singapore

Novartis Investigative Site, Singapore 169610, Singapore

Novartis Investigative Site, Basel 4031, Switzerland

Novartis Investigative Site, Bangkok 10700, Thailand

Novartis Investigative Site, Ankara 06100, Turkey

Novartis Investigative Site, Sutton SM2 5PT, United Kingdom

Novartis Investigative Site, Beijing, Beijing 100730, China

University of California at Los Angeles UCLA, Los Angeles, California 90095, United States

Novartis Investigative Site, Withington, Greater Manchester M20 4BX, United Kingdom

Lurie Children's Hospital of Chicago Clinical Research Office, Chicago, Illinois 60611, United States

Novartis Investigative Site, Nanjing, Jiangsu 210002, China

Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept of Onc, Baltimore, Maryland 21231, United States

Dana Farber Cancer Institute SC (2), Boston, Massachusetts 02115, United States

Karmanos Cancer Institute Oncology Department, Detroit, Michigan 48201, United States

Weill Cornell Medical Center Dept. of Oncology, New York, New York 10021, United States

Oregon Health & Science University Dept of Oncology, Portland, Oregon 97239, United States

Fox Chase Cancer Center Dept.ofFoxChaseCancerCtr., Philadelphia, Pennsylvania 19111-2497, United States

University of Texas/MD Anderson Cancer Center UT MD Anderson, Houston, Texas 77030-4009, United States

Additional Information

Starting date: March 2013
Last updated: May 15, 2015

Page last updated: August 23, 2015

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