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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


Phase 4
N/A
N/A
Not Enrolling
Both
GIST and CML

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients receiving imatinib

Outcome Description:

To allow continued use of imatinib

Outcome Time Frame:

Until no patients are left on study, with an expected average of 10 years

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CSTI571A2406

NCT ID:

NCT01742299

Start Date:

March 2013

Completion Date:

February 2018

Related Keywords:

  • GIST and CML
  • Glivec/Gleevec
  • CML
  • GIST
  • Imatinib mesylate

Name

Location

Northwestern University Clinical Research OfficeChicago, Illinois  60611
MD Anderson Cancer Center/University of Texas UT MD AndersonHouston, Texas  77030-4009
Dana Farber Cancer Institute SC (2)Boston, Massachusetts  02115
University of California at Los Angeles UCLALos Angeles, California  90095
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept of OncBaltimore, Maryland  21231
Weill Cornell Medical Center Dept OncologyNew York, New York  10021
Oregon Health & Science University Dept of OncologyPortland, Oregon  97239
Fox Chase Cancer Center Dept.ofFoxChaseCancerCtr.Philadelphia, Pennsylvania  19111-2497