Date: 2015-08-10
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Ariad Pharmaceuticals (USA - MA)
Product: Iclusig® (ponatinib)
Action
mechanism: kinase inhibitor. Iclusig® (ponatinib) is a kinase inhibitor. Its primary target is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukaemia (CML) and Philadelphia -chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Iclusig was designed using ARIAD\'s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets both native BCR-ABL and isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which is a common mutation among resistant patients.
Disease: refractory, chronic-phase chronic myeloid leukemia (CP-CML)
Therapeutic area: Cancer - Oncology
Country: USA, Europe
Trial
details: This is a multi-center, randomized, phase 2 trial to characterize the safety and efficacy of ponatinib over a range of 3 starting doses. Eligible patients must have chronic phase chronic myeloid leukemia (CP-CML) and be resistant to at least 2 tyrosine kinase inhibitors (TKIs). (NCT02467270)
Latest
news: * On August 10, 2015, Ariad Pharmaceuticals announced that the first patient has been treated in its OPTIC (Optimizing Ponatinib Treatment In CML) trial of Iclusig® (ponatinib). This randomized, dose-ranging trial is designed to evaluate three starting doses of ponatinib in patients with refractory, chronic-phase chronic myeloid leukemia (CP-CML) and is expected to inform the optimal use of Iclusig in these patients. Approximately 450 patients will be enrolled at clinical sites around the world. This study will enroll patients with CP-CML who are resistant to at least two approved TKIs. These patients will be randomized equally to receive once-daily administration of 45 mg (cohort A), 30 mg (cohort B) or 15 mg (cohort C) of ponatinib. Patients in cohorts A and B will have their daily dose reduced to 15 mg upon achievement of major cytogenetic response (MCyR). The primary endpoint of the trial is MCyR by 12 months for each cohort. Secondary endpoints include rate of vascular occlusive events in each dose cohort, rates of adverse events and rates of serious adverse events. Other secondary endpoints include cytogenetic, molecular and hematologic response rates, tolerability, duration of response, time to response, disease control rate, progression-free survival and overall survival. Preliminary data from the OPTIC trial is expected at the end of 2016. Patients will be enrolled at up to 90 cancer centers globally. * On January 6, 2015, Ariad Pharmaceuticals announced that it has concluded consultations with U.S. and European health authorities regarding the design of a randomized, dose-ranging trial to evaluate three starting doses of Iclusig® (ponatinib) in patients with refractory, chronic-phase chronic myeloid leukemia (CP-CML). The trial is expected to inform the optimal use of Iclusig in these patients and will begin by mid-2015. Approximately 450 patients will be enrolled at clinical sites around the world.This study will enroll patients with CP-CML who are resistant to at least two approved tyrosine kinase inhibitors. These patients will be randomized equally to receive once-daily administration of 45 mg (cohort A), 30 mg (cohort B) or 15 mg (cohort C) of Iclusig. Patients in cohorts A and B will have their daily dose reduced to 15 mg upon achievement of major cytogenetic response (MCyR). The primary endpoint of the trial is MCyR by 12 months for each cohort. Secondary endpoints include rate of vascular occlusive events in each dose cohort, rates of adverse events and rates of serious adverse events. Other secondary endpoints include cytogenetic, molecular and hematologic response rates, tolerability, duration of response, time to response, disease control rate, progression-free survival and overall survival. Interim reports will be submitted to the FDA and the European Medicines Agency, providing an opportunity to review safety and efficacy data collected during the trial. Patients will be enrolled at up to 90 cancer centers globally.
