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Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…

Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens

The primary purpose of the study is to determine the efficacy of AZD2281 compared to placebo in serous ovariancancer platinum sensitive patients and in a defined HRD subset.

Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year

Boosting Oxytocin after trauma: Neurobiology and the Development of Stress-related symptoms.

Primary aim:In recently traumatized individuals (at the latest on day ten post trauma exposure) with a high initial level of distress, we aim to assess the effectiveness of intranasal OT in preventing symptoms of PTSD at one months post intervention…

Medical Nutrition in prodromal Alzheimer's Disease, a double-blind controlled 24-month study, with four times a 12 month extension study.

To evaluate the effect of Souvenaid® on cognition in patïents with mild cognitive impairment after 24 months.

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM
SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN*S DISEASE (OPERA II)

The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary objectives: * The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.* Exploratory…

An Open-Label Extension of Study HGT-SAN-055 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Administration of rhHNS in Patients with Sanfilippo Syndrome Type A (MPS IIIA)

The primary objectives of this study are: • To determine the longterm safety and tolerability of rhHNS administered via an intrathecal (IT) route once monthly for 8 years in patients with MPS IIIA, who have received and tolerated 6 months of…

An open-label, single-arm, phase II, multicenter study to evaluate;the efficacy of vemurafenib in metastatic melanoma patients with brain metastases

The primary objective of this trial is to evaluate the efficacy of vemurafenib using BestOverall Response Rate (BORR), as assessed by an Independent Review Committee (IRC)using RECIST, v1.1 criteria in the brain of metastatic melanoma patients with…

Efficacy of ultrasound guided radiofrequency ablation of breast carcinomas <= 2cm

In this study we will evaluate the possibility to locally ablate small breast carcinomas with RFA. Finally this study should contribute to the replacement of the conventional lumpectomy by RFA.1) Can radiofrequency ablation (RFA) completely destroy…

A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the renal hemodynamic effects of RLX030 at a dose of 30 µg/kg/day or placebo infused for 24 hours in subjects with chronic heart failure (CHF).

Primary objective(s)To assess the effects of 24 hrs i.v. infusion of RLX030 30µg/kg/day compared to placebo on renal blood flow (RBF) as measured by PAH clearance in subjects with CHF and worsening symptoms To assess the effects of 24 hrs i.v.…

Phase I/II, multi-center, open label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ASP9521 in patients with metastatic castrate-resistant prostate cancer

The overall objective of this phase I/II three-part study is to evaluate the benefit of 12 weeks once daily dosing with ASP9521 in a population of patients with metastatic castrate resistant prostate cancer (CRPC) who have failed one or more lines…

A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects with Type 2 Diabetes Mellitus

The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion in subjects with type 2 diabetes mellitus (T2DM) with albuminuria.The primary safety objective of this study is to evaluate the…

In vivo imaging of ER density to guide and improve tailored therapy for acquired anti-hormonal resistant breast cancer

To discriminate the acquired anti-hormonal resistance phenotypes in patients based on ER expression levels by FES-PET in order to select patients eligible for estrogen therapy.

A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients with Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

The primary objectives are to:• Compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo.• Evaluate the safety of IPI-926 in patients with metastatic or…

A phase II, randomized, double-blind, placebo controlled, parallel design, dose ranging, multi-center trial of four levels of exposure of QGE031 s.c. for 16 weeks in subjects aged 18-50 years with peanut allergy (CQGE031A2208)

Primary: To characterize the QGE031 dose response relationship for the increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment.Secondary (only key parameters): The percentage of patients…

A phase II open-label, randomized, multi-centre comparative study of bevacizumab-based therapy in paediatric patients with newly diagnosed supratentorial, infratentorial cerebellar, or peduncular high-grade glioma.

To evaluate the efficacy, safety, tolerability, and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant temozolomide (TMZ) and to determine whether the addition of anti-angiogenic therapy with…

A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients with Refractory Chronic
Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia

Primary Objective:To determine the efficacy of ponatinib in patients with CML in CP, AP or BP or with Ph+ ALL who either:are resistant or intolerant to either dasatinib or nilotinib,Or:have the T315I mutation.Secondary Objectives:* To further…

Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial)

The objective of this study is to determine whether influencing the protein pathway thought to underlie TSC by Everolimus treatment will improve cognitive abilities in these children.

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB >= 66 years and very poor risk AML >= 18 years

Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of Lenalidomide added to standard induction chemotherapy for AML and select the feasible dose level for part B of the study2. To assess in a randomized…

Modifying Orphan Disease Evaluation (MODE) Study: A multicenter, open-label study of the
effects of CER-001 on plaque volume in subjects with Homozygous Familial
Hypercholesterolemia

The purpose of the study is to assess the effects of CER-001, given by intravenous infusion with regards to plaque burden of the carotid arteries and the descending thoracic aorta using 3T magnetic resonance imaging (3TMRI).The objective of the…