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A Phase 4 Safety and Efficacy Study of Bosutinib (Bosulif®) in Patients with Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated with One or More Tyrosine Kinase Inhibitors

The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the EMA in providing additional safety and efficacy data in approximately 150 patients with Ph+ CML whose disease had failed or who are otherwise not…

Patient Reported Outcomes in the CAstration-resistant Prostate cancer RegIstry

The objectives are to determine generic, cancer-generic and prostate cancer-specific HRQOL and costs outside the hospital in CRPC patients during treatment (including best supportive care, docetaxel, cabazitaxel, abiraterone and enzalutamide) in…

Personalizing enzalutamide (Xtandi®) therapy by understanding the relation between the decrease in the expression profile of a panel of preselected microRNAs, tumor related mRNAs and treatment response in patients with mCRPC (ILUMINATE)

Primary Objectives:To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95,…

An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated with the Investigational PI3K* Inhibitor, GS-9820

To provide idelalisib, a marketed PI3K* inhibitor, in lieu of GS-9820, an investigational second generation PI3K* inhibitor, to subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study closure.

Multinational study assessing the acceptability and determinants of compliance to HPV vaccination to women in screening ages 25 to 45 years

This study aims to identify global and local determinants of HPV vaccine acceptability, HPV vaccine uptake and compliance as well as identify logistics and programmatic issues in each country to offer the HPV vaccine, as a potential cervical cancer…

Influence of a fatty beverage (Milk) on the absorption of erlotinib: a randomized, cross-over pharmacokinetic study (MERLOT-study)

In this study we want to determine the erlotinib concentrations in blood after administration of erlotinib with water or whole milk with and without an antacid .

PHARMACOKINETICS OF CARBOPLATIN AFTER ADJUSTED DOSING FOR HIGH BMI, LOW SERUM CREATININE, AND MAXIMAL RENAL FUNCTION

The primary objective of the study is to determine the mean prediction error (MPE) and mean absolute prediction error (MAPE) of the area under the plasma concentration-time curve (AUC) of carboplatin after adjusted dosing for high BMI (BMI &gt…

Validation of digital-PCR analysis through programmed imatinib interruption in PCR negative chronic myeloid leukemia patients.

Primary ObjectiveTo assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.Secondary Objectives• To estimate…

AN OPEN-LABEL, EXTENSION (ROLLOVER) STUDY OF VEMURAFENIB IN PATIENTS WITH BRAFV600 MUTATION*POSITIVE MALIGNANCIES PREVIOUSLY ENROLLED IN AN ANTECEDENT VEMURAFENIB PROTOCOL

The primary objective of this study is to provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated in an antecedent vemurafenib protocol and did not meet the protocol*s…

Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)

Primary objective:To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC). Secondary objectives:To determine if occurrence of docetaxel toxicity can be related to dose/LBM.To…

Influence of an acidic beverage on the absorption of erlotinib

To determine the influence of the acidic beverage Coca-Cola, concomitantly taken with erlotinib (with or without a PPI), on erlotinib plasma pharmacokinetics compared to erlotinib concomitantly taken with water in cancer patients.

Individualizing Pazopanib therapy by exploRing the role of Early metabolic responsE and drug exposure as a preDICTor for treatment outcome in patients with STS

Primary Objectives:- To evaluate whether early metabolic response is correlated to clinical benefit (defined as PFS).- To evaluate the effect of age (>= 70 years) on pazopanib pharmacokinetics (AUC0-24hr).Secondary Objectives:- To evaluate…

An exploratory, open label, single-arm study to evaluate the effect of Eligard® 6-month on biomarkers of disease in patients with metastatic prostate cancer

To explore the effect of Eligard® on the following prostate cancer biomarkers:• Testosterone in serum• Prostate Specific Antigen (PSA) in serum• Prostate Cancer Antigen (PCA3 score) in urine • PSA mRNA in blood/PBMC• PCA3 mRNA in blood/PBMC• TMPRSS2…

Diarrhea during use of the oral angiogenesis inhibitors sunitinib and sorafenib

To identify what might be the cause of the occurrence of diarrhea during the use of angiogenesis inhibitors sunitinib and sorafenib in patients with a malignancy.

Primovist enhanced MRI for the detection and evaluation of focal liver lesions

To make an efficacy evaluation of Gadolineum Ethoxybenzyl (Gd-EOB) DTPA-enhanced MR-imaging (Gadoxetic acid, Primovist, Bayer Schering Pharma, Berlin) and Respiratory Triggered Diffusion Weighted Imaging (DWI) for the detection and characterization…

Impact of new approaches to pharmacological management of patients with renal cell carcinoma: a population-based study of process and outcomes in The Netherlands

The 1st main objective is to collect detailed quantitative data on the everyday management of mRCC in the Netherlands, the clinical outcome of this management, as well as the resulting quality of life and financial costs. Treatment selection for…

A SINGLE ARM OPEN LABEL INTERNATIONAL MULTI CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT®) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS.

Evaluating the efficacy and safety of sunitinib in patients with progressive, advanced/metastatic well-differentiated, unresectable pancreatic neuroendocrine tumors.

An International, Randomised, Double-Blind, Two-Arm Study to Evaluate the Safety and Efficacy of Vandetanib 150 and 300 mg/day in Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma with Progressive or Symptomatic Disease.

The primary objective of this study is to assess the objective response rates (ORR) for two starting doses of vandetanib, 150 mg and 300 mg in patients with unresectable locally advanced or metastatic MTC having progressive or symptomatic disease.…

An open-label, multi-center everolimus roll-over protocol for patients who have completed a previous Novartis-sponsored everolimus study and are judged by the investigator to benefit from continued everolimus treatment

Primary: To allow continued use of everolimus to patients receiving everolimus in a Novartis-sponsoredstudy which has reached its objectives and who are benefitting from treatment with everolimus as defined in the parent protocolSecondary: To…

prediction of everolimus-induced interstitial lung disease in breast cancer patients; maximizing efficacy by reducing toxicity

Primary objective:Analyze the value of pneumoproteins, everolimus exposure, pulmonary function tests, distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the prediction of the…