An open label, multi-center nilotinib roll-over protocol for patients who have completed a previous Novartis-sponsored nilotinib study and are judged by the investigator to benefit from continued nilotinib treatment

ovartis Farma S.p.A.0 个研究点目标入组 300 人开始时间: 2013年2月19日最近更新: 2013年8月19日

适应症

试验速览

暂无简介。

•1. Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study.
•2. Patient is currently benefiting from the treatment with nilotinib, 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.
•Other inclusion criteria as defined in the protocol apply.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•1. Patient has been permanently discontinued from nilotinib 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 nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy.
•3. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study.
•4. 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.
•5. 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 nilotinib. Male patients must use highly effective contraception during the study and for 30 days after the final dose of nilotinib.
•Other exclusion criteria as defined in the protocol apply.

发起方

ovartis Farma S.p.A.