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A prospective study to determine the value of chromosomal instability in selecting treatment of head and neck mucosal lesions.

Primary objectives:(1) Prevent progression of precursor lesions of the head and neck mucosa by treating selected lesions at risk for malignant outgrowth(2) Demonstrate that the detection of chromosomal instability (CIN) is indeed a powerful tool to…

A randomized, double-blind placebo- and active-controlled study of the pharmacokinetics, pharmacodynamics and safety of single ascending doses of HM10660A (LAPS-Interferon Alpha-2B) in healthy male subjects

to study the safety and tolerability of HM10660A (LAPS-interferon alpha-2b), including immunogenicity, as compared to Pegasys® (PEG-interferon alpha-2a)to study the pharmacokinetics and pharmacodynamics of HM10660A (LAPS interferon alpha-2b) as…

Comparison of outcome with three different needles in ultrasound assisted fine needle aspiration cytology (FNAC) of the thyroidal gland.

Primary objective: to obtain an comparison of the diagnostic result after an ultrasound assisted fine needle aspiration cytology (FNAC) of the thyroidal gland by use of a smaller diameter (25G) and / or a special coating.

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer - Cachexia (NSCLC-C): An Extension Study;(ROMANA-3)

Based on the data available, Anamorelin HCl produces an increase in total body weight and Lean Body Mass in patients with advanced cancer, and specifically in patients with NSCLC, in addition to increasing muscle strength and improving quality of…

An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Cisplatin and Pemetrexed With or Without Cixutumumab as First Line Therapy in Patients with Advanced Nonsquamous Non Small Cell Lung Carcinoma

The primary objective of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell…

A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

This study will evaluate the antitumor activity of RAD001 versus placebo in patients with angiomyolipoma associated with either TSC or LAM.

A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC)

This study will evaluate the antitumor activity of RAD001 versus placebo in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).

A confirmatory, placebo-controlled, randomised, double-blind, single-dummy, parallel group, ratio-finding study in constipated pain patients to establish an optimal hydromorphone â¤* naloxone ratio with an improved bowel function and a comparable analgesic efficacy compared to hydromorphone alone

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A combined physical exercise and psychosocial training program to improve physical fitness in children with cancer.

The proposed study is part of a larger KWF program proposal: the Alpe d*HuZes Cancer Rehabilitation Research Program (A-CaRe) coordinated by the EMGO Institute. The aim of the study is to evaluate the short- and long-term effectiveness of a combined…

Effects of a multifaceted *teleguided* pain care programs in patients with cancer

The aim of this study is to evaluate the effect of the intervention regarding pain intensity and quality of life as compared to care as usual. Secondary outcomes of the effect evaluation are self-efficacy, knowledge, depression and anxiety, and…

Dendritic cell vaccination in patients with Lynch Syndrome or colorectal cancer with MSI

The primary objective is the safety and feasibility of CEA/frameshift derived neopeptide loaded DC in patient with MSI-positive colorectal cancer and persons who are known to be carrier of a germline MMR-gene mutation with no signs of disease yet.…

A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…

An exploratory, open label, multicenter study to investigate pharmacodynamic of RO5083945, a human monoclonal antibody antagonist of Epidermal Growth Factor Receptor (EGFR), compared to cetuximab in patients with operable head and neck squamous cell carcinoma.

This study looks at the impact of RO5083945 compared to cetuximab in patients with HNSCC. The study also evaluates the behavior of these drugs within the body and their mechanism of action on head and neck tumor cells and on the immune system cells…

A randomized trial in cancer-related fatigue in palliatively treated patients: protocolized patient-tailored treatment of physical symptoms (PPT) vs care as usual (CAU)

The objective of this study is to determine the effectiveness of receiving a multidisciplinary protocolized patient-tailored treatment of physical symptoms (PPT) in combination with structurally monitoring of reported symptoms (the intervention) on…

Development and effectiveness of a webbased psycho-educational self-management intervention for breast cancer patients.

The purpose of this study is to develop a webbased intervention for breast cancer patients to reduce the impact of psychological problems that arise after the completion of medical treatment at an early stage. The question is whether this…

To enhance return-to-work in cancer patients - a randomised controlled trial

Primary objective: to determine the effect of the intervention on return-to-work and quality of life. Secondary objectives: To determine the effect of the intervention on the work ability and work limitations. To determine the feasibility of the…

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Followed by an Open-Label Extension Phase

The objective of this study is to evaluate the safe use of JNJ-42160443 compared to placebo and to demonstrate whether patients JNJ-42160443 will, in addition to their standard treatment for pain, more pain relief than more patients receiving…

Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab

Primary objectives:1) To determine whether concurrent ATII-antagonist treatment can prevent trastuzumab-related cardiotoxicity, defined as a decline in LVEF of more than 15% or a decrease to an absolute value <45%Secondary objectives:1) To…

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma

To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with advanced cancers and bone metastases (or lytic bone lesions from multiple myeloma).SRE is…

First-in-human phase I safety, pharmacokinetic, and pharmacodynamic study of G1T28-1 in healthy male and female subjects.

The purpose of the study is to investigate to what extent G1T28-1 is tolerated. It will also be investigated how quickly and to what extent G1T28-1 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, a possible…