19 results
The aim of the phase Ib part is to estimate the MTD and/or identify the RP2D for the combination MEK162 and panitumumab, followed by a phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected…
The purpose of this clinical research study is to compare the effect of panitumumab to cetuximab (Erbitux®) in treating metastatic colorectal cancer in patients whose tumor contains the wild-type (unchanged) KRAS gene and who have previously been…
The overall study objective is to assess the efficacy, safety, and tolerability of 2 laquinimod doses, 0.6 mg/day or 1.2 mg daily (QD), in a double-blind design compared to Avonex® (rater blinded) once weekly (QW)Study objectives:* To evaluate the…
A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of…
This study is a phase I trial. Primary objective is to evaluate the safety of combined radiotherapy with Panitumumab in bladder preservation in invasive bladder cancer. Secondary objectives are to investigate the efficacy of combined radiotherapy…
Primary Objective: Description of the 1-year overall survival after chemo-radiation therapy with or without panitumumab in irresectable carcinoma of the oesophagus. The control arm is used to validate whether the historical cohort used for…
Phase I part To determine the recommended safe dosing for the combination of chemoradiation with gemcitabine plus panitumumab in patients with inoperable locally advanced pancreatic cancer.Phase II part 1) To investigate the proportion of patients…
The purpose of the study is to investigate the effect of etrasimod on the values of specific ECG parameters. Importantly, the study will assess whether there is a prolongation of the QT interval following etrasimod treatment. When the QT interval is…
Main objective: SSAThe safety, tolerability, and efficacy of 2 doses of etrasimod as induction therapy in subjects with moderately to severely active Crohn's disease (CD)SS1 - Cohort 1The dose-response relationship of 2 doses of etrasimod vs…
Part 1 primary objectives: To determine the safety, tolerability and range of tolerated combination doses in subjects with BRAF-V600E mutation-positive CRC intwo dosing groups:* dabrafenib dosed orally in combination with panitumumab * trametinib…
Main objective:*To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active Crohn's disease (CD).*To select an oral etrasimod dose, based on efficacy and…
PART I: 1) to demonstrate 89Zr-cetuximab uptake in non-hepatic tumor lesions at standard dose or at cohort wise increased cetuximab doses (dose escalation). 2) to determine the association between 89Zr-cetuximab uptake in non-hepatic tumor lesions…
- Primary Objective:To evaluate the safety and tolerability of investigational regimens of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors- Secondary Objectives:To characterize PK of product(s) used in investigational…
Primary:* To evaluate the effects of etrasimod on esophageal eosinophilia in adult subjects with active eosinophilic esophagitis (EoE)* To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo in adult subjects with active…
Primary Objectives• To describe the anti-tumor activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with an advanced solid tumor, multiple myeloma or non-Hodgkin lymphoma that harbours a genomic…
To determine the median progression-free survival (PFS) and R0/1 secondary resection rate upon induction systemic treatment in colorectal cancer patients with initially unresectable liver-only metastases, stratified by RAS and BRAF tumor mutation…
The primary objective is to assess the efficacy of etrasimod when administered for 12 weeks on clinical remission in subjects with moderately to severely active ulcerative colitis (UC). The secondary objective is to assess the efficacy of etrasimod…
The primary objective is to the safety of long term administration of etrasimod in subjects with moderately to severely active UC. The secondary objective is to assess the the long-term efficacy of etrasimod in subjects with moderately to severely…
The primary objective is to assess the efficacy of etrasimod on clinical remission in subjects with moderately to severely active ulcerative colitis (UC) after 12 and 52 weeks of treatment. The secondary objective is to assess the efficacy of…