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Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…

Efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in well differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel® 120 mg administered every 28 days.

Objectives:Primary:• To assess progression free survival (PFS) when treated with lanreotide Autogel® 120 mg administered every 14 days based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.0, and according to central review.Secondary:•…

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…

Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year

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.

A Phase I, Open-label, Single Dose Study to Evaluate the Disposition, Metabolism, and Excretion of Radiolabelled [14C]-BIM23B065 Following Subcutaneous Administration in Healthy Male Subjects

The purpose of the study is to investigate how quickly and to what extent BIM23B065 is distributed, metabolized (broken down) and excreted from the body, and what the main route of excretion from the body is (urine or feces); this is called…

AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER PHASE I/II TRIAL OF RO5424802 GIVEN ORALLY TO NON - SMALL CELL LUNG CANCER PATIENTS WHO HAVE ALK MUTATION AND FAILED CRIZOTINIB TREATMENT

The primary objectives for Part 1:-To determine the recommended Phase II dose of RO5424802 to be used in Part 2 of the study-To evaluate the safety and tolerability of 600mg and 900mg doses of RO5424802 administered twice daily to subjects with…

A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas (BCCs).

The primairy objective of this fase II study, is to compare two treatment regimens of vismodegib in two populations of patients with multiple BCC's (patients with Gorlin syndrome and patients who do not have Gorlin syndrome). Primary to assess…

A phase I trial of actively personalized peptide vaccinations plus immunomodulators in patients with newly diagnosed glioblastoma concurrent to first line temozolomide maintenance therapy

Primary objective of this study is to assess the safety and tolerability, feasibility and biological activity (immunogenicity) of the actively personalized vaccination (APVAC) concept in newly diagnosed glioblastoma (GB) patients.Secondary study…

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…

PROSPECTIVE FASE-II TRIAL EVALUATING THE OUTCOME OF INDUCTION CHEMOTHERAPY FOLLOWED BY EXTENDED LYMPH NODE DISSECTION AND CHEMORADIATION FOR HIGH RISK INVASIVE BLADDER CANCER

- To evaluate the bladder-preservation rate after chemoradiation - To evaluate the toxicity and complications of treatment with induction chemotherapy followed by ePLND and chemoradiation

A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

In this study, we explore the correlation between baseline intratumoral CD8+ cell density and objective response rate (ORR) as well as other biomarker parameters in subjects with unresected stage IIIB to IVM1c melanoma treated with talimogene…

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.

89Zirconium-labeled nivolumab and 18F-labeled anti-PD-L1 as predictive imaging biomarkers of response and toxicity in nivolumab treated patients with non-small-cell lung cancer * a feasibility study

To assess uptake of 18F-PD-L1 and 89Zr- nivolumab in tumor lesions.

Targeted vessel ablation of type 3 uterine fibroids with magnetic resonance guided high intensity focused ultrasound

To investigate whether it is possible to manipulate perfusion in type 3 fibroids with MR-HIFU.

GLOBAL STUDY TO ASSESS THE ADDITION OF BEVACIZUMAB TO CARBOPLATIN AND PACLITAXEL AS FRONT-LINE TREATMENT OF EPITHELIAL OVARIAN CANCER, FALLOPIAN TUBE CARCINOMA OR PRIMARY PERITONEAL CARCINOMA

Zie pagina 39-40 van het protocol MO22923 versie 2, 26 Mei 2011

A Phase 2, randomized, open-label, multicenter study to assess safety and efficacy of nab®-paclitaxel
(ABI-007) with epigenetic modifying therapy of CC-486, and nab®-paclitaxel
monotherapy as second-line treatment in subjects with advanced nonsquamous non-small cell
lung cancer (NSCLC): ABOUND.2L

To assess the efficacy of nab-paclitaxel administered intravenously (IV) on Days 8and 15 with epigenetic modifying therapy of CC-486 once daily (QD) on Days 1 to14 every 21 days, and nab-paclitaxel monotherapy administered IV on Days 1 and 8every 21…

Improving CNS penetration of radiolabeled TKI PET tracers through PgP/BCRP inhibition

The primary objective of this study is to obtain clinical proof of principle that the addition of a PgP/BCRP inhibitor increases CNS concentrations of tyrosine kinase inhibitors by inhibition of drug efflux transporter function in the blood brain…

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…

Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men

The objective of the current proposal is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts > 350 x 10E6/l and intra-anal high-grade, HPV16 positive AIN, who failed on…