9 results
Primary objectives:Part A: To determine the recommended phase 2 dose and schedule (RP2D) of the selumetinib/afatinib combination in patients with KRASm and PIK3CAwt NSCLC and CRCPart B: To determine the progression free survival (PFS) of the…
ObjectivesPrimary objective1. To assess the efficacy of selumetinib in combination with dacarbazine compared with placebo in combination with dacarbazine in terms of Progression Free Survival (PFS) assessed by blinded independent central review (…
Primary:To evaluate the effects of 15 mg E4/3 mg DRSP, of 30 mcg EE/150 mcg LNG, and of 20 mcg EE/3 mg DRSP on hemostasis, endocrine function and lipid and carbohydrate metabolism parameters during 6 treatment cycles.Secondary:To assess the safety…
Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…
To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation negative locally advanced or…
To assess the efficacy, measured as progression free survival, and safety of Selumetinib in combination with docetaxel, compared to docetaxel alone, in patients receiving second line treatment for KRAS mutation-positive, locally advanced or…
Objectives:Primary objective:To evaluate the efficacy of the 3 selected dose regimens of Padsevonil (PSL) administered concomitantly with up to 3 antiepileptic drugs (AEDs) compared with Placebo for treatment of observable focal-onset seizures in…
Objectives:Primary objectiveTo evaluate the long-term safety and tolerability of padsevonil (PSL) administered at individualized doses between 100 mg/day and 800 mg/day as adjunctive treatment for subjects with focal-onset seizures and drug-…
Phase IPrimary Objective- To define the recommended phase II dose (RP2D) of selumetinib/dexamethasone combination in adult and paediatric patients with relapsed/refractory, RAS pathway mutant ALLSecondary Objectives- To evaluate safety and…