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