29 results
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…
Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…
Primary Objectives-To compare the efficacy responses of CP-690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP-690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16-week double-blind…
(1) To assess the effect of ARA 290 on the ventilatory response to hypoxia (and compare the effects to Epo); (2) To assess the effect of ARA 290 on the gradient over the tricuspid valve during hypoxia (and compare the effects to Epo); (3) To assess…
The goal of this study is to document the efficacy of a shortened 8-week therapy with grazoprevir and elbasvir in patients with acute HCV genotype 1 or 4 infection.
The primary efficacy objective for this study is to evaluate the efficacy of MPDL3280Ain patients with PD-L1*positive locally advanced or metastatic NSCLC, as measuredby investigator-assessed ORR according to modified RECIST.SECONDARY OBJECTIVESThe…
To test the hypothesis that LY3314814, administered orally at doses of 20 and 50 mg daily for 78 weeks, will slow the decline of AD ascompared with placebo in patients with mild AD dementia.
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 (…
The objectives of this open-label extension*safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety…
Primary objective: To test the hypothesis that treatment with LY3074828 is superior to placebo in the proportion of subjects with endoscopic response at Week 12, defined as 50% reduction from baseline in SES-CD ScoreSecondary objective: • To…
Primary Objective:The primary objective of this study is to determine the feasibility of four weeks of preoperative immunotherapy with Arm A nivolumab (240 mg q2w), Arm B nivolumab (240 mg q2w) plus relatlimab (80 mg q2w), and arm C nivolumab (240…
To evaluate the ongoing safety, tolerability, and efficacy parameters of pegunigalsidase alfa in adult Fabry patients who have successfully completed studies PB-102-F20 and PB-102-F30, or completed at least 48 months in study PB-102-F03.
The primary objective is to investigate the rate of pathological responses following different neoadjuvant immunotherapy combinations in high-risk non-metastatic clear cell RCC in an adaptive trial design. And to study the safety and feasibility of…
The objective of this phase III study is to evaluate the efficacy and safety of Tozorakimab according to 300 mg every 8 weeks (Q8W) and 300 mg every 4 weeks (Q4W) dosing regimens administered in adult participants with symptomatic COPD and a history…
Primary objectives:Dose Escalation• To assess the safety and tolerability of JDQ443 single agent and JDQ443 in combination with TNO155, JDQ443 in combination with tislelizumab, and JDQ443 in combination with TNO155 and tislelizumab, and to identify…
All primary and secondary objectives will compare zanubrutinib (also known as BGB-3111) plus rituximab followed by zanubrutinib monotherapy versus bendamustine plus rituximab followed by observation only.Primary:• To compare efficacy, as measured by…
Primary objective:- To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients with subset of T1 to T3N0 NSCLCOsimertinib cohort:- To assess the efficacy of osimertinib following SoC SBRT by 4…
1. Primary Objective The primary objective of this study is to assess the effect of lanifibranor alone compared toplacebo and the effect of lanifibranor in combination with empagliflozin compared to placeboon HbA1c after a 24-week treatment duration…
Main objective:Dose Escalation Part:• To assess the safety and tolerability of DF1001, and to determine the Maximum Tolerated Dose (MTD) of DF1001 in patients with Advanced (unresectable, recurrent, or metastatic) solid tumors for whom no effective…
Objectives:Primary: To evaluate the long-term safety of IVT injected pegcetacoplanSecondary:1. To assess changes in the total area of geographic atrophy (GA) lesion in the study eye measured by fundus autofluorescence (FAF).2. To assess changes in…