34 results
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…
In this study we want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by the EGFR tyrosine kinase inhibitor erlotinb and metformin, combined with gemcitabine in patients with metatastatic pancreatic…
The primary objective of this study will be to determine the pharmacokinetic profile of lorazepam oral liquid 1 mg/ml in the paediatric ICU population, with specific attention for the population aged up to 12 years of age.The secondary objectives…
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…
Primary objectiveTo investigate whether the addition of preoperative radiochemotherapy to the standard treatment, consisting of explorative laparotomy, pancraticoduodenectomy if possible, followed by adjuvant chemotherapy, improves the overall…
Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…
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…
To evaluate the efficacy and toxicity of gemcitabine in combination wth 131I-MIBG in pediatric patients with relapsed or progressive neuroblastoma.
Aim of the study is to investigate what the influence is of insomnia on driving performance and to what extent this influence is attenuated by the use of hypnotics. Therefore, over-the-road driving performance of treated and untreated patients…
To demonstrate superiority with regard to Progression Free Survival based on an Independent Review Committeeassessment of avelumab versus platinum-based doublet in NSCLC subjects with PD-L1+
The primary objective of this study is to compare the overall survival (OS) associated with rAd-IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM…
Primary objectives:1. Determine the potential improvement of the duration of progression-free survival by maintenance treatment with gemcitabine. Secondary objectives:1. To compare the objective radiological response (ORR) rate2. To compare overall…
Primary:* To determine if alisertib improves overall response rate (ORR; complete response [CR] plus partial response [PR]) versus a selection of single agents in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)* To determine…
The aim of this study is to evaluate the efficacy of a personalized drug profiling method using short-term cultures of malignant cells derived from the patient*s pleural fluid.
To provide subjects who have completed participation in a Phase 2 or Phase 3 trial continued access to therapy and to evaluate the long-term safety and tolerability of leuco-methylthioninium bis(hydromethanesulfonate) given in flexible doses of up…
The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator*s choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have relapsed…
Primary Objective:• To assess and compare efficacy of sacituzumab govitecan to TPC as measured by progression free survival (PFS) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1…
The purpose of this multi-cohort study is to assess the safety and efficacy of tusamitamab ravtansine (SAR408701) in mBC and mPAC participants with CEACAM5 positive tumors which are known to be sensitive to taxanes.
Primary ObjectivesPart I- To define the Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D) of CAN04 once weekly (Q1W) in subjects with relapsed or refractory NSCLC, PDAC, TNBC or CRC.Part II- To determine the safety and tolerability of…
Primary Objective part A:* To evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered BIW in subjects withadvanced solid tumors* To determine the MTD and/or RP2D of single-agent M4344 administered BIW in…