Search for a trial

A Phase IA, multicenter, open-label dose escalation study of BKM120, administered orally in adult patients with advanced solid malignancies

Primary objectiveTo determine the maximum-tolerated dose (MTD) of BKM120 as a single agent when administered orally to adult patients with advanced solid tumorsSecondary objectives* To assess the safety and tolerability of BKM120* To characterize…

Pharmacodynamic assessment and exploration of cerebral changes in relation to fatigue of antiangiogenic treatment in cancer patients

The study is divided in two parts. In the first part, we will study our hypothesis that the biological activity of antiangiogenic therapy is partly mediated by inhibition of platelets. We will study whether antiangiogenic agents inhibit the…

Potential Carcinogenic Effects of Endovenous Laser Ablation

This study will determine the concentration of benzo[a]pyrene before and after EVLA.

A phase I, multi-center, open-label, drug-drug interaction study to assess the effect of the CYP1A2 inhibitor, fluvoxamine, on TKI258 (dovitinib) pharmacokinetics in patients with advanced solid tumors.

Primary objectivesTo evaluate the effect of the CYP1A2 inhibitor, fluvoxamine, on steady state pharmacokinetics of TKI258 in patients with advanced solid tumors, excluding breast cancerSecondary objectives• To characterize the safety and…

A phase 1 multicenter, open label, dose-escalation study of oral LEE011 in patients with advanced solid tumors or lymphomas.

Primary To determine the maximum tolerated dose (MTD) and characterize the dose-limiting toxicities (DLT) of LEE011 when administered orally once daily for 21 consecutive days followed by a 7 day break.Secondary *Safety and tolerability of LEE011.*…

Open-Label Multicenter 2-Arm Phase I Study of RO5429083 with Dose-Escalation and Extension Cohorts, and Imaging Cohorts with RO5429083 and 89Zr-labeled RO5429083, in Patients with Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Arm A-Dose Escalation CohortPrimary Objectives* To describe the pharmacokinetics (PK) and safety profiles (including the maximum tolerated dose (MTD) or Optimal Biological Dose) of escalating doses of RO5429083 in patients with metastatic and/or…

Weekly administration of (bi-)daily Oral Docetaxel in combination with Ritonavir

The primary objective is to determine the maximum tolerated dose (MTD) of docetaxel (as ModraDoc001) that can safely be administered to patients with cancer in a bi-daily weekly schedule.

Phase I study of Everolimus combined with Metformin for patients with advanced cancer

To determine the dose limiting toxicity (DLT) and the maximum tolerated dose and recommended dose of the combination of everolimus orally once daily and metformin orally BID to patients with advanced solid tumors.

A pilot phase I open-label study to assess the safety and tolerability of Olaparib, a poly-(ADP-ribose)polymerase (PARP) inhibitor, in combination with melphalan for the treatment of patients with homologous recombination deficient metastatic solid tumors

To perform a pilot study to determine the feasibility of conducting a two-arm phase I trial and to determine the recommended dose level for phase II (RP2D) study and assess the safety of the combination olaparib and melphalan in patients with…

Effect of deep neuromuscular block and variations in arterial PCO2 on the surgical rating scale, extubation conditions and postoperative conditions following reversal with sugammadex

To assess whether the implementation of a deep neuromuscular block (NMB) (PTC 1-2) combined with induction of relative hypocapnia creates optimal surgical conditions as measured by the surgeon (using the 5-point Leiden surgical rating scale) versus…

An open-label, non-randomized, single-center, Phase I trial to investigate the mass balance and the metabolite profile of cilengitide in five healthy subjects

Primary:- To evaluate the mass balance of total 14C radioactivity, i.e. PK parameters of cilengitide and potential metabolites,- To quantify the route(s) of excretion in urine (14C and cilengitide) and feces (14C), - To profile potential metabolites…

Absorption and excretion of docetaxel (as ModraDoc 005 tablets) after oral administration in combination with ritonavir.

To quantitatively determine the absorption and excretion of docetaxel (as ModraDoc005 10 mg tablets) after administration of a single low dose and a single high dose of oral docetaxel in combination with ritonavir.

A phase IA, multicenter, open-label dose escalation study of oral BYL719, in adult patients with advanced solid malignancies, whose tumors have a alteration of the PIK3CA gene.

Primary* To determine the maximum tolerated dose or recommended phase 2 dose of oral BYL719 as single agent and in combination with fulvestrantSecondary* To assess the overall safety and tolerability of BYL719 as single agent and in combination with…

Changes in body composition in patients with cancer in the upper airway and digestive tract: a prospective study

Primary aim of this study is to assess changes in body composition in patients with a carcinoma in the larynx, pharynx or oral cavity, in the period during and after treatment.Secundary aims of this study are:- to assess predictive factors for…

A phase Ib multi-center, open-label, 4-arm dose-escalation study of oral BEZ235 and BKM120 in combination with weekly paclitaxel in patients with advanced solid tumors and weekly paclitaxel/trastuzumab in patients with HER2+ metastatic breast cancer.

Primary:Dual-agent dose escalation part (Part 1):• To determine the maximum tolerated dose of oral, daily (qd) BEZ235 in combination with paclitaxel, qw in patients with advanced solid tumors(MTD1, Arm 1).• To determine the maximum tolerated dose of…

An Open-Label Study to Investigate the Pharmacokinetics (Distribution, Metabolism, and Excretion) of Bendamustine Hydrochloride Following Intravenous Infusion of [14C]Bendamustine Hydrochloride in Patients With Relapsed or Refractory Malignancy (Hematologic or Nonhematologic)

The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…

Phase I/II study of combined treatment with AT-101, cisplatin and radiotherapy in patients with locally advanced head and neck cancer

Primary objective:The main objective of this study is to assess the feasibility, tolerability and the maximum tolerated dose (MTD) of oral AT-101 in combination with concurrent cisplatin-based chemotherapy and radiotherapy (RT) in advanced HNSCC, as…

Evaluation of E7050 Pharmacokinetics after 100 mg Single Oral Doses Under Fed and Fasted Conditions and Characterization of E7050 Pharmacokinetics after 100 mg, 200 mg and 400 mg Single Oral Doses Under Fasted Condition in Healthy Subjects

Primary: * To determine the effect of food on the bioavailability of E7050 following oral administration of a tablet containing 100 mg E7050 with and without a standard low- or high-fat breakfast (Part A)* To characterize E7050 pharmacokinetics…

Problem-Solving Therapy to reduce distress in patients with cancer: a randomized clinical trial and investigation of mechanisms of change

To test the effects of a problem-solving therapy to reduce distress and increase quality of life in patients with cancer. Also to test the mechanisms of change of the therapy.

EPC quantification after G-CSF stimulation in healthy volunteers

Primary objective is:To determine whether a single subcutaneous injection of G-CSF induces an immediate (within six hours) release of bone marrow progenitor cells in healthy volunteers.