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Completed
NCT01742299
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
Conditions: GIST and CML
Sex: All
Ages: 0 Years – 100 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 250
Sponsor: Novartis Pharmaceuticals
Location: University of California LA Los Angeles California
Summary
The purpose of this study is to better characterize the long-term safety of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Global Development \& Global Medical Affairs (OGD\&GMA) study and are benefiting from the treatment as judged by the investigator.
Eligibility Criteria
Inclusion Criteria:
* Patient is currently enrolled in a Novartis-sponsored, Global Drug Development \& Global Medical Affairs study receiving imatinib and has fulfilled all their requirements in the parent study.
* Patient is currently benefiting from the treatment with imatinib, as determined by the investigator.
* Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
* Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
* Written informed consent obtained prior to enrolling in roll-over study.
* If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
Exclusion Criteria:
* 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.
Highly effective contraception is defined as either:
* Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. 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 total hysterectomy, bilateral 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 \
Source: ClinicalTrials.gov (NCT01742299). StuddyBuddy aggregates publicly available trial information.