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A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer

Primary Objectives(1) To evaluate the overall survival (OS) of subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic…

DIetary REstriction as an adjunct to neoadjuvant ChemoTherapy
for HER2 negative breast cancer

PrimaryDoes a peri-chemotherapeutic FMD ameliorate grade III or IV toxicity (Phase II part) and increase pathologic complete response (pCR) in patients with HER2 negative early breast cancer treated with neoadjuvant chemotherapy (Phase III part).…

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…

A prospective, multicenter, randomised, open-label, active controlled, 2 parallel groups, phase 3 study to compare the efficay and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor after progression with imitinib

The objective is to compare the efficacy and safety of masitinib 12 mg/kg/day to sinutinib 50 mg/day

A phase Ib/II, multicenter, open label, study of LEE011 in combination with MEK162 in adult patients with NRAS mutant melanoma

Primary objective: Phase Ib (see study design): Maximum Tolerated Dose(s) and/or Recommended Phase II Dose (RP2D) of LEE011 and MEK162 in combination. Phase II (see study design): Assess the anti-tumor activity of the LEE011 and MEK162 combination…

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…

Holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: HEPAR Primary

Primary objective:To establish the safety and toxicity profile of 166Ho-RE in patients with hepatocellular carcinoma. Secondary objectives:* To evaluate efficacy of 166Ho-RE in hepatocellular carcinoma without curative treatment options in a non-…

A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib
(AZD6244, Hyd-Sulfate) in Combination with Dacarbazine Compared with
Placebo in Combination with Dacarbazine as First Systemic Therapy in
Patients with Metastatic Uveal Melanoma (SUMIT)

ObjectivesPrimary objective1. To assess the efficacy of selumetinib in combination with dacarbazine compared with placebo in combination with dacarbazine in terms of Progression Free Survival (PFS) assessed by blinded independent central review (…

A phase II, multicenter, open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer (CEGF816X2201C)

Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…

Olaparib dose escalation in combination with high dose radiotherapy to the breast and regional lymph nodes in patients with breast cancer

To define the maximal tolerated dose (MTD) of olaparib in combination with radiotherapy of the breast and regional lymph nodes in patients with breast cancer without the use of skin bolus (arm A) or with the use of skin bolus (arm B).

A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of Rifampicin (a CYP3A4 Inducer) on the Pharmacokinetics of AZD9291 in Patients with EGFRm Positive NSCLC whose disease has Progressed on an EGFR TKI

To investigate the effect of a CYP3A4 inducer (rifampicin) on the PK of AZD9291.

The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

COLDFIRE-2 study: Colorectal metastatic liver disease: efficacy of irreversible electroporation (IRE) - a phase II clinical trial

The primary objective of this project is to evaluate the primary and secondary technique effectiveness of IRE for centrally located colorectal liver metastases that are neither amenable for resection nor for other local ablation methods due to the…

Hypofractionated Focal Lesion Ablative Microboost in prostatE cancer (Hypo-FLAME)

The main goal of this phase II study is to investigate whether a focal ablative SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT. Based on the present study, a phase III…

Dutch randomized multicenter trial COmparing twO PalliativE RAdiaTION schemes for incurable head and neck cancer (COOPERATION)

to investigate the oncologic outcomes, toxicity and QoL of two commonly used palliative radiation schemes in the Netherlands

Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer

- Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.- Secondary study objectives: Establish and compare…

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…

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence

The purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

Study ObjectivesTo compare the efficacy of POM + BTZ + LD-DEX with BTZ + LD-DEX in subjects with relapsed or refractory MM Secondary Objectives:To evaluate the safety and additional efficacy of POM + BTZ + LD-DEX versus BTZ + LD-DEX in subjects with…

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Biological Activity of SAR405838 in Patients with Advanced Cancer.

Primary objective* To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs).* To assess biological activities of SAR405838 in patients with dedifferentiated liposarcoma…