21 results
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
The purpose of the study is to delineate the upstaging percentage of pN0 patients by detection of micrometastases (pN0micro+) and evaluate the benefits from adjuvant chemotherapy on disease recurrence in pN0micro+ CC patients.
Primary: Progression free survival.Secondary: Toxicity, overall survival, response rate, duration of response, translational research.
The primary objective of the study is assessment of the dose limiting toxicity (DLT) and maximal tolerated dose (MTD) of docetaxel, oxaliplatin and capecitabine given in combination in patients with advanced cancer of the stomach or the gastro-…
To investigate wether neo-adjuvant chemotherapy followed by cytoreductive syurgery and hyperthermic chemotherapy is feasible and reduces the number of irresectable patients with acceptable morbidity and mortality rates.
To assess the response rate to the combination of gemcitabin plus oxlaiplatin in 5 different strata of relapsed/refractory pediatric solid tumors, in whom standard treatment has failed. Secondary objectives are the safety, the duration of response,…
Firstly, determination of the maximum tolerated dose (MTD) , dose limiting toxicity (DLT) and farmacokinetics in IHP with sequential administration of oxaliplatin and melphalan.Secondly, evaluation of toxicity, tumor response and survival after IHP…
Primary objective: to detect an increase in progression free survival (PFS*, see chapter 7.3.6) rate at 1 year in each experimental arm (mFOLFOX6 + bevacizumab or panitumumab) compared to mFOLFOX6 alone arm as perioperative treatment for resectable…
To confirm the effect of continious subcutaneous insulin infusion (CSII treatment) with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 diabetes Mellitus, using a…
The purpose of this study is to investigate the effect of treatment with two courses of chemotherapy followed by immunotherapy. Immune therapy stimulates the body's immune response directed against the tumor. In addition, the goal is to…
Part 1:The purpose of Part 1 of the study is to investigate how much of the OZ439 compound is absorbed into, distributed in, and eliminated from the body (this is called pharmacokinetics) when administered orally as compared to an intravenous (iv;…
Phase I study to investigate safety of the combination indomethacin and two platinum-based chemotherapy regimens in patients with advanced cancers.
The primary objective is to assess the feasibility of administering adjuvant S-1 and oxaliplatin in patients with esophageal cancer after neoadjuvant chemoradiotherapy with paclitaxel and carboplatin and esophagectomy
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
Primary Objective: disease related treatment failure.Secondary Objectives: Overall survival, CRM negative (margin > 1 mm) rate, Pathological complete response (pCR) rate, Short and long-term toxicity, Surgical complications, Quality of life.…
The primary objective of this study is to compare overall survival rates of CRC patients with multi-organ metastases with indication for first line palliative systemic treatment for mCRC, randomized for treatment with combination chemotherapy or…
Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and the regular dose.Secondary objectives1. To determine whether boosting reduces the inter- and intrapatient PK…
Primary objective:To compare Arm A relative to Arm B on event-free survival (EFS)Key secondary objectives:- To compare Arm A relative to Arm B on overall survival (OS)- To compare Arm A relative to Arm B on pathological complete response (pCR) rate