28 results
Primary:Dual-agent dose escalation part (Part 1):• To determine the maximum tolerated dose of oral, daily (qd) BEZ235 in combination with paclitaxel, qw in patients with advanced solid tumors(MTD1, Arm 1).• To determine the maximum tolerated dose of…
To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…
To demonstrate efficacy of adjuvant combination chemotherapy in a randomized phase III trial comparing to no further treatment in the medium and high-risk node negative stage I and stage II patients.
The primary objective of the phase I part of the study is to determine the recommended phase II dose of metformin in combination with carboplatin/paclitaxel chemotherapy in patients with advanced ovarian cancer. The secondary objectives the phase I…
The goal of this registry study is to provide insight in the safety and efficacy of treatment with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient antero-lateral branches (<12 mm) and insifficincy of the…
4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…
Primary objective· • To investigate the safety and tolerability and establish either the dose of KU-0059436 which causes inhibition of PARP in combination with an active dose of carboplatin or the maximum tolerated dose (MTD) of KU-0059436 in…
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.
Main objective: response rate and tumour size reduction by neoadjuvant chemotherapy.
Primary: • Evaluate the safety of TIL, alone or with IFNα, in patients with recurrent platinum sensitive EOC during standard chemotherapy (carboplatin and paclitaxel).Secondary: • Evaluate signs of activity and underlying mechanisms (response rate,…
Objective: To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, withrespect to progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator.
1) Objective: To compare pembrolizumab plus chemotherapy to placebo plus chemotherapy with respect to PFS
•To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between sacituzumab govitecan (SG) versus treatment of physician*s choice (TPC)Secondary Objectives:•To compare overall survival (OS) between the 2…
To evaluate efficacy of image-guided de-escalating chemotherapy in the presence of dual HER2-blockade with Herceptin® and pertuzumab in HER2-positive breast cancer, as measured by three-year event-free survival.Secondary objectives• To evaluate 3-…
Main objective:Dose Escalation Part:• To assess the safety and tolerability of DF1001, and to determine the Maximum Tolerated Dose (MTD) of DF1001 in patients with Advanced (unresectable, recurrent, or metastatic) solid tumors for whom no effective…
Modified objectives after implementation of protocol amendment February 2017: Primary: 1. Validate the BRCA-like test* in predicting differential PFS with first line alkylating and platinum agents when compared to paclitaxel in TNBC Secondary: 1.…
To compare the overall survival of patients with relapsed or refractory GCT treated with conventional-dose chemotherapy using the TIP regimen (CDCT) with patients treated with high-dose chemotherapy (HDCT) plus ASCT using the TI-CE regimen as…
• To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectable gastric cancer
Possibly, outcomes of treatment of irresectable squamous cell carcinoma of the esophagus can be improved by adding bintrafusp alfa to treatment with definitive chemoradiotherapy. As a first step we aim to know whether the addition of bintrafusp alfa…
This study is designed to assess the efficacy and safety of pembrolizumab monotherapy compared with SoC platinum doublet chemotherapy for first-line treatment of participants with dMMR advanced or recurrent EC. The primary objectives are to compare…