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A non randomised open pilot study in palliative care: investigating the feasibility and preliminary effectiveness of an exercise program in palliative cancer patients

The aim of this study is to determine the feasibility and preliminary effectiveness of an exercise program in cancer patients with metastasis and/or relapse, and to explore other limitations than physical fitness and their effect on physical…

Open-label phase I study to investigate the effect of multiple doses of tasquinimod on the single-dose pharmacodynamics and pharmacokinetics of warfarin in healthy subjects

Primary: To assess the effect of multiple doses of tasqinimod on the single-dose pharmacodynamics (PD) of warfarin. Secondary: To assess the effect of multiple doses of tasqinimod on the single-dose pharmacokinetics (PK) of warfarin. To assess the…

A study on the pharmacokinetics and repeatability of [18F]Fluoromethylcholine PET-CT in patients with prostate cancer

The aims of the present study are: 1. to create a tracer kinetic model for quantification of [18F]FCH and simultaneously validate a simplified quantitative method, and 2. to assess the repeatability of the latter method.

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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Effects of aprepitant (Emend ®) on the pharmacokinetics of fentanyl.

Primary Objective: - to study the influence of administration aprepitant (Emend ®) on the clearance of fentanyl, in patients using a stable dose of the fentanyl patch (Durogesic ®).Stable dose is defined as using the same dose of fentanyl during at…

Bioavailability of oral ciprofloxacin tablets versus suspension in pediatric cancer patients

To determine the relative bioavailability of ciprofloxacin oral suspension versus oral tablets in pediatric cancer patients, and to determine the absolute bioavailability of tablets and suspension utilizing the 100% bioavailability of intravenous…

A single arm open label multicentre extension study of bevacizumab in patients with solid tumours on study treatment with bevacizumab at the end of a F. Hoffmann-La Roche and/or Genentech sponsored study.

To provide continued bevacizumab therapy as single agent or in combination with an anti-cancer drug to patients with cancer, who were previously enrolled in a F. Hoffmann-La Roche (Roche)/ Genentech sponsored bevacizumab study (i.e. the Parent, P-…

Generation of precursor T cells dor the development of adoptive T cell therapy for patients after stem cell transplantation.

The ultimate goal is to develop an early T cell reconstition therapy to combine with HSCT to treat and cure patients with hematological cancers. In this stage, thus for this project, we need to investigate if we can make in vitro T cell from CD34+…

Weekly administration of Oral Docetaxel in combination with Ritonavir

To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…

Long-term safety of trastuzumab in patients with HER2-positive breast cancer

Primary objective • To explore changes in left ventricular ejection fraction (LVEF) values before, during and after trastuzumab treatment Secondary objectives• To explore the reversibility of congestive heart failure associated with trastuzumab…

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…

An open-label, individual study groups, fixed sequence, four-period crossover study comparing three proportionate sizes of HP 3020 patch applied for 24 hours with intravenous palonosetron injection (ALOXI®) and a one-period study with one size of HP-3020 patch applied for 168 hours, to investigate the pharmacokinetics, tolerability and safety of HP-3020 patches in healthy male subjects

Primary: To investigate the pharmacokinetics of palonosetron in plasma from three different sizes of HP-3020 transdermal patch applied for 24 hours as compared to intravenous palonosetron (Cohort 1) and to investigate the pharmacokinetics of…

PHASE I-II STUDY OF GEMCITABINE AND VALPROIC ACID PLUS VALGANCICLOVIR IN PATIENTS WITH ADVANCED NASOPHARYNGEAL CARCINOMA

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…

An open-label, parallel group study to explore the pharmacokinetics of eribulin (E7389) in patients with advanced solid tumors and normal or reduced hepatic function according to the Child Pugh system.

To study the influence of hepatic impairment on plasma pharmacokinetic parameters of eribulin mesylate (E7389) following an IV administration.

An Open-Label, Non-Randomized, Single-Center Study to Determine the Metabolism and Elimination of 14C-E7080 in Patients with Advanced Solid Tumors or Lymphomas, who are Unsuitable For, or Have Failed, Existing Therapies

Primary objective:To determine the pharmacokinetics of E7080 and its excretion balance in order to elucidate its metabolic profile in plasma, urine, and feces following a single oral dose of radiolabeled 14C-E7080 in patients with advanced tumors or…