Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
Condition: Chronic Myelogenous Leukemia (CML); Metastatic Gastrointestinal Stromal Tumors (GIST); Acute Lymphoblastic Leukemia (ALL); Receptor Tyrosine Kinase (KIT) Mutated Melanoma
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors
Intervention: Nilotinib
Intervention description: Patients who were on nilotinib treatment in a Novartis-sponsored study (parent study) and were benefiting from nilotinib treatment met the criteria for enrolment into the CAMN107A2409 study and to receive continued nilotinib treatment. The starting dose of nilotinib in the CAMN107A2409 study should have been the same as the last dose administered in the parent study. After the starting dose, the dose of nilotinib was based on the investigator's judgement. The dose of nilotinib should have been ≤ 800 mg/day for adult patients, 230mg/m2 body surface area (BSA) and ≤ 800 mg/day for pediatric patients.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Healthy volunteers: No
Keywords: metastatic gastrointestinal stromal tumors (GIST); Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP),; adult; Chronic myelogenous leukemia (CML); chronic myeloid leukemia (CML); chronic myelocytic leukemia (CML); Acute Lymphoblastic Leukemia (ALL); Philadelphia chromosome positive; Acute Lymphoid Leukemia; suboptimal molecular response; Tasigna; CML; GIST; nilotinib

Summary:

      The purpose of this study was to allow continued use of nilotinib in patients who were on
      nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs
      (CD&MA) study and were benefiting from the treatment as judged by the investigator
    

Eligibility criteria:

        Inclusion Criteria:

        -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 -Patient is currently benefiting from the treatment with nilotinib, 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

        Exclusion Criteria:

        - 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 - 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 -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 -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 nilotinib.