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neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination with Anastrozole to those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy with Abemaciclib in Combination with Anastrozole in Postmenopausal Women with Hormone Receptor Positive, HER2 Negative Breast Cancer

The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…

A multicenter randomized phase III study to compare the combination trastuzumab and capecitabine, with or without pertuzumab, in patients with HER2-positive metastatic breast cancer that have progressed after one line of trastuzumab-based therapy in the metastatic setting (PHEREXA)

To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).

Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma (CTCL)

The main purpose of this study is to determine if KW-0761, an investigational drug will work against cutaneous T-cell lymphoma (CTCL) that has failed to respond to other treatments, and to evaluate its side effects. An investigational drug is one…

A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)

Primary: superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma.Secondary: overall survival, best overall response, duration of response, non-melanoma skin lesions,…

The effect of curcumin and piperine on the pharmacokinetics of tamoxifen in patients with breast cancer *the ELDORADO study*

The main objective is: To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).Secundary objectives are:1. Other pharmacokinetic outcomes (i.e. clearance, minimum…

Effects of a short-term dietary restriction regimen in cancer patients receiving irinotecan.

Primary objective is to demonstrate a 25% reduction of the active irinotecan metabolite, SN38, in healthy liver tissue in patients with mCRC or other solid tumors as a result of preceding dietary restriction five days in advance. Secondary…

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 .

The effects of the proton pump inhibitor esomeprazole on the bioavailability of regorafenib in patients with a metastatic colorectal cancer (mCRC) or gastrointestinal stromal tumour (GIST).

To determine the influence of esomeprazole on the AUC of regorafenib in patients with mCRC or GIST.

Proof of principle and pharmacological phase 0 crossover study with controlled release capecitabine (ModraCape001)

Primary objective is to determine the plasma pharmacokinetics of ModraCape001 and compare these to the pharmacokinetic profile of Xeloda®.Secondary objectives are:• To determine the AUC in blood plasma of capecitabine and its metabolites 5-dFCR, 5-…

POLYP DETECTION WITH THE PEERSCOPE SYSTEM*: A RANDOMIZED TANDEM COLONOSCOPY STUDY

To compare the additional diagnostic yield obtained by using the PeerScope System* extended view vs. the diagnostic yield obtained by the Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and…

A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN*S LYMPHOMA GRADES 1, 2 OR 3A

To evaluate the proportion of patients indicating an overall preference via a Patient Preference Questionnaire (PPQ) for either the subcutaneous (SC) or the intravenous (IV) route of rituximab administration.

A Phase II multi-center, open label, randomized study to assess safety and efficacy of two different schedules of oral LDE225 in adult patients with relapsed/refractory or untreated elderly patients with acute leukemia

During the last several years, substantial progress has been made regarding the biologic characterization of the acute leukemias. The traditional understanding that myeloid leukemic cells are developmentally similar to their normal hematopoietic…

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.

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…

An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820, Administered as a Once Daily and Twice Daily Oral Dose to Determine the Maximum Tolerated Dose in Subjects with Unresectable Solid Tumors

Part A Food Effect StudyPrimary Objective• To determine the effect of a high fat meal on oral bioavailability of 50 mg E7820 in comparison with fasting conditions.Secondary Objectives• To determine the safety and tolerability of E7820.• To determine…

"Effects of Cimetidine on Cisplatin-induced Nephrotoxicity"

2.5 Study rationaleThe nephrotoxicity caused by cisplatin is of great concern both in that it is dose-limiting and can be detrimental to the patient. Much work has been done to reduce or prevent this damage to renal cells, however to date the best…

A phase II study of cediranib as palliative treatment in patients with symptomatic malignant ascites or pleural effusion

Primary objective:To assess the puncture free survival after start of treatment with cediranib (time to first need for paracentesis or thoracentesis or time to death, which event occurred first)Secondary objectives:-To assess the palliative effects…

Development and introduction of a pediatric liquid formulation of mercaptopurine for treatment of leukemia

The aim of this study is to improve 6MP treatment in pediatric leukemia patients, by developing and licensing a pediatric liquid formulation of 6MP, assessing its stability and bioequivalence, and ensuring a nationwide introduction of the new…

TRUSTS: A phase IIb/III multicenter study comparing the efficacy of TRabectedin administered as a 3-hour or 24-hour infusion to doxorubicin in patients with advanced or metastatic Untreated Soft Tissue Sarcoma.

Phase IIb: To evaluate the most effective dosing schedule of trabectedin.Phase III: To evaluate whether trabectedin given as 1st line chemothearpy for advanced/metastatic soft tissue sarcoma prolongs progression free surivival, as compared to…

Effects of the co-administration of budesonide on the plasma exposure of cabazitaxel (Jevtana??) in castrate resistant prostate cancer patients

Primary objectives:- To study the potential interaction of budesonide on the plasma exposure of cabazitaxelSecondary objectives:- To test the safety of concomitantly administrating cabazitaxel and budesonide in terms of potential side effects