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A phase Ib, open-label, multi-center, dose escalation and expansion study of an orally administered combination of BKM120 plus MEK162 in adult patients with selected advanced solid tumors

Primary:To determine the MTD and/or RP2D of BKM120 and MEK162 in combination when administered orally to adult patients with selected advanced solid tumors. Secondary:• To characterize the safety and tolerability of the oral combination of BKM120…

A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers (BET115521)

Primary:To evaluate the clinical activity of GSK525762 in NUT Midline Carcinoma and other solid tumors.Secondary:Effect of treatment with GSK525762 on tumor growth and survival. Pharmacokinetics of GSK525762. Safety.

Hyperthermia and PARP-1 inhibition in recurrent head&neck or bladder cancer

Primary:To establish a recommended phase II dose of the PARP-inhibitor olaparib in combination with hyperthermia in a) patients with recurrent HNC in previously irradiated area and in b) patients with primary irresectable or local recurrent bladder…

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies

To investigate the safety and tolerability of AZD5363 and to define a recommended dose when given orally, either as a continuous or an intermittent schedule, for further clinical evaluation when given to patients with advanced solid malignancies.

Treatment of Targeted Therapy-Related Fatigue in Patients with CML or GIST: A Single-Case Experimental Design

To investigate the efficacy of cognitive behaviour therapy (CBT) on reducing TTF in patients receiving TKIs for CML or GIST.

Optimizing abiraterone (zytiga®)therapy by exploring the relation between an early biomarker-drug exposure-as a predictor for drug response in patients with mCRPC (OPTIMUM study)

Primary Objectives:*To explore whether early abiraterone exposure (AUC) is corre*lated to treatment response after 3 months and 6 months of therapy (primarily based on radiographic response (RECIST re*sponse: SD, PR, CR) and secondary on…

A Phase I Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of CriPec® docetaxel in Patients with Solid Tumours.

Circulating CriPec docetaxel nanoparticles are designed to be in a higher degree than the original compound (docetaxel) to be trapped in tumor tissue due to the enhanced penetration and retention (EPR) effect. Subsequent release of docetaxel from…

Development and clinical activity of low dose metronomic chemotherapy with oral paclitaxel

We will develop a bi-daily low-dose metronomic treatment schedule with paclitaxel in a convenient oral formulation and test whether this therapy has significant anti-angiogenic and anti-tumor activity.

A phase I, multicenter, open-label dose escalation and expansion study of LOP628, administered intravenously in adult patients with cKit-positive tumors and acute myeloid leukemia

Primary objective: To estimate the MTD/RDE of LOP628 in solid tumors and AML, respectively.Secondary objectivesL:- To characterize the safety and tolerability of LOP628- To characterize the pharmacokinetic profile of LOP628- To assess emergence of…

Olaparib dose escalation trial in patients treated with radiotherapy for laryngeal and oropharyngeal squamous cell carcinoma

To define the maximal tolerated dose (MTD) of olaparib in combination with radiotherapy in laryngeal and oropharyngeal SCC.

A phase I, first time in human, open-label, dose escalation study to investigate the safety, pharmacokinetics, and pharmacodynamics of anti-HER3 monoclonal antibody GSK2849330 in subjects with advanced HER3-positive solid tumors

Primary: To evaluate the safety of GSK2849330 in a larger population of subjects in molecularly-defined tumor histology groups at the dose regimen(s) recommended for further exploration in Part 1. Secondary: Clinical benefit, pharmacodynamics,…

A Phase 1 Study of ABT-767 in BRCA1- or BRCA2-Mutation Carriers with Advanced Solid Tumors and in Subjects with High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The primary objective of this study is to assess the safety, tolerability, and pharmacokinetics of ABT-767 and the effect of food on ABT-767 bioavailability in subjects with BRCA1 or BRCA2 germ line mutation and associated solid tumors (e.g. breast…

An open label positron emission tomography (PET) imaging study using 89Zirconium to investigate the biodistribution of anti-HER3 monoclonal antibody (mAb) GSK2849330 and characterize its dose receptor occupancy relationship in subjects with advanced HER3-positive solid tumors

To measure in vivo biodistribution of 89Zirconium labeled GSK2849330 and characterize its dose receptor occupancy relationship in subjects with advanced HER3 positive solid malignancies.

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 Phase I, Open-Label, Multicentre Study to Compare Two Dosage Formulations of AZD5363 and to Establish the Effect of Food on the Pharmacokinetic Exposure, Safety and Tolerability of AZD5363 in Patients with Advanced Solid Malignancies (OAK)

Part A: to compare the PK exposure of a new AZD5363 tablet formulation with that of the AZD5363 capsule formulation in patients with advanced solid malignancies.Part B: to explore the effect of a standardised meal on the PK exposure of a new tablet…

An Open Label Study to Investigate the Pharmacokinetics (Absorption, Distribution, Metabolism, and Excretion) of Omacetaxine Mepesuccinate Following Subcutaneous Administration of [14C]c in Patients with Relapsed and/or Refractory Hematologic Malignancies or Advanced Solid Tumors.

Primary Objective: The primary objective of the study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism, and excretion) of [14C]omacetaxine mepesuccinate and its metabolites in patients with relapsed and/or…

Use of individual PK-guided pazopanib dosing: A feasibility study in patients with advanced solid tumors

primary• To determine the safety and feasibility of PK guided dosing of pazopanib secondary• Evaluation of the dried blood spot procedure• To determine the objective response rate (according RECIST 1.1)• To determine the time to tumor progression…

Development of an assay for detection of Circulating Endothelial Cell (CEC) and Circulating Endothelial Progenitor cell (CEP) by fluorescence-activated cell sorting (FACS) in cancer patients and healthy individuals.

Produce a reproducible method for enumeration of CECs and CEPs in peripheral blood in order to further study the usefulness of CECs and CEPs as a biomarker in LDM therapy.

Long-term treatment for cancer patients with deep vein thrombosis or pulmonary embolism - a randomized open label study

The primary efficacy objective is to evaluate whether LMWH is superior to VKAs in the long-term treatment of symptomatic VTE in cancer patients who completed 6 to 12 months of anticoagulant treatment. Two aspects are important: the efficacy with…

A two parts, biomarker study to identify genetic aberrations predictive for response on Everolimus in solid tumors without regular treatment options (CPCT*03)

Primary objective first part: analyse a set of 1951 genes for prediction of response measured by progression free survival ratio (TTP1:TTP2) on mTOR inhibition.Primary objective second part: to assess the ratio of progression free survival (TTP1:…