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A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS

Safety (Primary) ObjectiveThe primary objective for this study is as follows:- To evaluate the safety and tolerability of cobimetinib in children and young adults, including estimation of the maximum-tolerated dose (MTD) or the maximum administered…

A Phase II, global, randomized study to evaluate the efficacy and safety of Danirixin (GSK1325756) co-administered with a standard-of-care antiviral (oseltamivir), in the treatment of adults hospitalized with influenza (study 201023, DAHLIA)

Primary:To assess the efficacy of treatment with IV danirixin twice daily given with oral oseltamivir compared to oral oseltamivir twice daily on time to clinical response (TTCR)Secondary:Time to respiratory response (TTRR), clinical measures of…

Topical treatment of perianal dermatitis with potato protease inhibitor cream in children after colorectal surgery.

To address the hypothesis that a potato derived protease inhibitor cream significantly limits perianal dermatitis in patients after colorectal surgery.

RANDOMIZED PHASE 2 TRIAL COMPARING EXPERIMENTAL IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 S.C.,GM-CSF) IN RECURRENT HIGH RISK NEUROBLASTOMA PATIENTS WITH STANDARD IMMUNOTHERAPY (ANTI-GD2 ANTIBODY, IL-2 I.V., GM-CSF) IN PATIENTS WITH RECURRENT AND NEWLY DIAGNOSED HIGH RISK NEUROBLASTOMA

Primary end points:Safety (>1 toxic death per arm) and tolerability (relevant grade 4 toxicities) in not more than 33% of patients for the three treatment arms.Secondary end points:* Reduction of grade 2-4 key side effects in the experimental…

A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric acute myeloid leukemia: the U-DANCE-anti-AML trial

Although DC vaccinations have been used in allo-HCT settings, no previous studies have been performed using a CBDC vaccine after CBT. This study will therefore be subdivided into 2 parts:- Part A: to determine a safe dose of the vaccination, and -…

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors.

Primary Objective:To compare the efficacy of BMS-986142 versus placebo on a background of MTX as assessed by ACR20 and ACR70 response rates at week 12.Secondary Objectives:1) Assess additional efficacy outcomes of BMS-986142 at week 12 and over 12…

Phase 2 multicenter study determining the response to Cabazitaxel in metastatic prostate cancer (mCRPC) patients with AR-V7 positive or negative circulating tumor cells (CTCs): CARVE

The primary objective of this study is to explore the PSA response rate to cabazitaxel in mCRPC patients who have progressed to docetaxel and to correlate the PSA response to AR-V7 expression in CTCs. Exploratory objectives include documenting the…

EMDR and stalking: a multiple baseline trail on reducing the urge to stalk

The objective of this study is primarily to answer the question if the EMDR Feeling State Addiction Protocol van Miller (2010), can contribute in reducing the urge to stalk. Participating clients are in treatment at De Waag (a out patient forensic…

Umbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.
A feasibility study focussing on engraftment and hematopoietic recovery.

To study the feasibility of single UCBT with one ex-vivo SR-1 expanded unitTo assess side effects and TRM after single UCBT with one expanded unitTo assess engraftment and engraftment kinetics; to evaluate immune reconstitution, acute and chronic…

A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 in patients with active psoriatic arthritis

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An investigation of the Effect of Long-Term Electrical Stimulation on Esophageal Acid Exposure in Pediatric Patients with Gastroesophageal Reflux Disease (GERD)

Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.

A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.

Primary ObjectiveTo determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective(s)To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.

An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 in Subjects WithNeuropathic Pain From Lumbosacral Radiculopathy

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.

Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculosis after successful intensive-phase treatment.

Primary endpoint: Evaluation of the safety of the novel anti-TB vaccine RUTI® (25*g FCMtb) in patients with MDR-TB favourably responding to second-line, standard MDRTB treatment through clinical, microbiological, and radiological response criteria.…

SAKK 06/14. A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy

The objective of the trial is to determine safety, tolerability and efficacy of VPM1002BC, in order to establish this medication as a therapy for non-muscle invasive bladder cancer in the future.

A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT).

Primary Objective:Efficacy:· Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population.Secondary Objectives:Safety:· Assess the safety and…

The Efficacy of TRH in Intensive Care patients; a dose finding study

To determine the minimal dose of protirelin that is effective and safe to normalize plasma thyroid hormone levels in patients with prolonged critical illness.

Phase I/II study with galunisertib (LY2157299) combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer and an
activated TGF-* signature

Part I of this study is designed to identify the recommended phase 2 dose of the combination regimen of galunisertib/capecitabine as second line treatment in patients with 5-FU or capecitabine resistant colorectal carcinoma. Part II is designed to…

A Phase Ib/II Multicenter, Randomized, Open Label Trial to Compare Tepotinib (MSC2156119J) Combined with Gefitinib Versus Chemotherapy as Second-line Treatment in Subjects with MET Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation and Having Acquired Resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy

To evaluate whether the efficacy in terms of progression free survival (PFS) of second-line tepotinib in combination with gefitinib is superior to pemetrexed+cisplatin/carboplatin in subjects with T790M negative, MET+ locally advanced or metastatic…

Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients with MYC Alterations

This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 in subjects 18 years and older with RR DLBCL, including those with MYC Alterations.