36 results
• To determine the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non myeloablative (NMA)) for…
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…
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 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…
The primary objective of this study is to evaluate the PK of POS administered orally at three dosage levels to immunocompromised children with expected neutropenia (selected oncology patients, aplastic anemia patients and patients which undergo a…
Aim of the present study is to assess normal values of EGJ distensibility in healthy volunteers.
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…
Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
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…
To compare overall survival (OS) of patients with metastatic (Stage IV) PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.
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.
To evaluate the efficacy and toxicity of gemcitabine in combination wth 131I-MIBG in pediatric patients with relapsed or progressive neuroblastoma.
The primary objective of the Phase 2 part of the study is to determine if overall survival(OS) in patients with Stage II-IV unresectable pancreatic cancer administered LY2603618 and gemcitabine combination therapy exceeds gemcitabine monotherapy OS.…
Primary objective:The primary objective of the trial is to evaluate efficacy, as measured by overall survival (OS), of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with previously untreated…
The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous…
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…