33 results
Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…
The aim of this extension trial is to provide BIBF 1120 treatment for all patients who have completed the 52 weeks treatment period and the follow up period in the phase III placebo controlled parent trial 1199.34, who may have experienced benefit…
Primary objective* To estimate efficacy for each study stratum at 18 weeks as assessed by RECISTKey Secondary objectives:* To estimate overall survival (OS) and progression free survival (PFS) in patients with advanced NSCLC* To determine safety and…
to evaluate the effects of GH versus withdrawal of GH, after final height is reached, on weight, body composition, psychosocial functioning, carbohydrate metabolism, circulating lipids, and respiratory function during transition period until the age…
Primary Objective During Double-Blind Period:To compare the efficacy of BMS-945429 SC versus placebo on a background of methotrexate as assessed by ACR20 response rates at 12 weeks.Secondary Objectives During Double-Blind Period:1) To assess…
The primary objective of this study is to assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on adult height and the first and five year growth response. Secondly, we want to assess the long term…
The primary objective of this study is to assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on adult height. Secondly, we want to assess the first and five year growth response, the long term…
Next to cardiovascular risk factors (main objectives: body composition and lipid profile; secondary objectives: remainder) we investigate the effect of GH treatment on glucose metabolism, physical performance, and neuropsychological functioning of…
Objectives:• To allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy orcombination) protocols, who are tolerating study drug and displaying clinical benefit.• To assess long-term safety and…
To determine the maximum tolerated dose, dose limiting toxicity and recommended Phase 2 dose of BMS-753493 in subjects with advanced cancer.
Primary Objective• For Arms A, B, and C: Determine the overall response rate (RR) of EZN-2208 for two distinct cohorts of patients with mCRC- Patients with mutated K-RAS tumors (Arm A)- Patients with wild-type K-RAS tumors (Arms B and C)• For Arms B…
to offer continuation of BIBF 1020 treatment for patients with IPF who have completed a prior clinical trial with that drug.establish the long term tolerability and safety profile of BIBF 1120 in IPF.
To determine if PHA-739358 has an antitumor activity against breast, ovaria, pancreatic, colerectal, small and non small cell squamous lung cancer.
Therapeutic exploratory study (Phase II).The purpose of this study the efficacy of a new compound (CPD323) for the treatment of Relapsing Remitting Multiple Sclerose (RRMS).CDP323 is a small chemical molecule. It is taken orally (by mouth) as a…
Primary objectivesTo evaluate the effect of the CYP1A2 inhibitor, fluvoxamine, on steady state pharmacokinetics of TKI258 in patients with advanced solid tumors, excluding breast cancerSecondary objectives• To characterize the safety and…
To assess the impact of 7 daily subcutaneous gifts of GH on circulating Klotho levels in human sugjects with CKD stage III and healthy age-matched controls.
The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.
The primary objective of this study is to assess the relation between the short term metabolic changes after start of rhGH therapy and the long term change in height SDS after one and two years of treatment. Secondly, we want to assess the effects…
The objective of this study is to compare the overall survival of patients with castration resistant prostate cancer who have progressed after receiving docetaxel treatment, when they are treated with bone directed radiotherapy plus Ipilimumab…
The primary aim of this study is to determine the Maximum Tolerated Dose (MTD) of BIBW2992 treatment in combination with cetuximab in patients with Non-Small Cell Lung Cancer with acquired resistance to erlotinib or gefitinib.Safety,…