99 results
Phase 1Primary objective- To determine the maximum tolerated dose (MTD) and recommended phase 2 dose level (RDL) of lenalidomide administered during 21 days of a 4 week cycle, combined with continuous cyclophosphamide and prednisone. See paragraph…
Primary objective:To evaluate the single- and multiple-dose safety and pharmacokinetics of CNM-Au8 upon oral administration of CNM-Au8 to healthy adult male and female subjects.Secondary objective:Exploreing the immune-modulating effects of CNM-Au8…
To improve overall survival of patients with a early-stage high grade uterine leiomyosarcoma.
The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.
Primary:The primary objective is to determine the safety and tolerability of the combination treatment, i.e. GCb, VPA and GCV, by evaluation of adverse events (AE*s) serious adverse events (SAE*s) and all clinically significant changes in clinical…
The primary objective of this study is to assess the objective response rate (ORR, the percentage of treated patients in whom the tumor significantly reduces in size or becomes non-detectable) of SAR240550 administered as a 60min intravenous…
The primary objective is to study whether treatment with the mTOR inhibitor Everolimus results in an objectable change in phosphorylation of the selected downstream effectors 4eBP1 and p70S6K in human prostate cancer biopsies. A secondary objective…
Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the…
The aim of the study is to assess if a dose reduction of craniospinal irradiation in children with a medulloblastoma does not reduce event free survival (EFS) or overall survival (OS). Furthermore it will be assessed if a field reduction (only tumor…
To determine the MTD toxicity of standard dose cetuximab together with concurrent individualized, isotoxic accelerated radiotherapy and cisplatin-vinorelbine.
The primary objective of the study is to determine if the treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic…
The primary objective of the trial is to evaluate whether L-BLP25 administered as weekly subcutaneous vaccinations with or without pretreatment with intravenous cyclophosphamide (CPA) induces a change in immune response parameters (ELISpot against…
The purpose of this study is to find out if the combination of gemcitabine plus carboplatin and iniparib works better than gemcitabine and carboplatin alone in subjects with stage IV squamous non-small-cell lung cancer (NSCLC) that have not…
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
Primary objectives:- To improve the clinical effectiveness of the p53 synthetic long peptides vaccine by pre-administration of cyclophosphamide.- To evaluate the immunogenicity of a p53 synthetic long peptide vaccine when preceded by administration…
The objective of this phase III study is to compare the efficacy of sorafenib in combination with gemcitabine and cisplatin versus placebo with gemcitabine and cisplatin for first-line treatment of patients with stage IIIB (with effusion) or Stage…
We expect to finalize the current phase I study by the May 2008 demonstrating that injection of tumor lysate-pulsed autologous DCs injected in patients with MM after chemotherapy is safe and well tolerated with induction of immune responses. New…
Objectives:Primary Objective:* To compare the overall survival (OS) distributions of RP101 and gemcitabine to placebo and gemcitabine in subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinomaSecondary Objectives:* To…
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…
Primary objective:· To determine the disease control rate as defined by RECIST assessment criteria [Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) rates] for both Vinflunine-Gemcitabine and Vinflunine-Carboplatin combinations.…