Kurzfassung

Open -label, multi-centre, dose escalating first-in- human Phase I study aimed at determining the maximum tolerated dose (MTD) of PDC31 in patients with symptomathic primary dysmenorrhea. For safety, patients will be dosed at a rate of not greater than 1 patient per day. Dose-escalation will be governed by the modified Continual Reassessment Method (mCRM) which calls for treating patients at the current best estimate of MTD. The Maximum tolerated Dose (MTD) is defined as the dose level that...Open -label, multi-centre, dose escalating first-in- human Phase I study aimed at determining the maximum tolerated dose (MTD) of PDC31 in patients with symptomathic primary dysmenorrhea. For safety, patients will be dosed at a rate of not greater than 1 patient per day. Dose-escalation will be governed by the modified Continual Reassessment Method (mCRM) which calls for treating patients at the current best estimate of MTD. The Maximum tolerated Dose (MTD) is defined as the dose level that is estimated to produce DLTs in 33% of patients. As such doses will be escalated or decreased after careful evaluation of each patient´s outcomes. In the absence of any DLT´s. allocation of remaining patients to dose levels below the MTD will be guided by effects of PDC31 on uterine contractilily.» weiterlesen» einklappen