26 results
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.
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…
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.
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…
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…
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,…
The two main objectives of the study are:* To assess the efficacy of ADT in treatment naïve patients with recurrent and/or metastatic, androgen receptor (AR) expressing, SGCs. The primary measure of efficacy is Progression-Free Survival (PFS).* To…
Primary Objective• To compare the event-free survival (EFS) by blinded independent central review (BICR) in Arm A (vs Arm B participantsSecondary Objectives• To compare the overall survival (OS) in Arm A vs Arm B participants• To assess the…
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…
The primary objective of this study is to evaluate the effect of HIPEC on overall survival when added to primary cytoreductive surgery in patients with FIGO stage III ovarian cancer who are eligible for primary cytoreductive surgery resulting in no…
To compare two (standard) treatment regimens in patients with KRAS mutated advanced stage NSCLC as first line treatment.
Main objective: response rate and tumour size reduction by neoadjuvant chemotherapy.
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.
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…
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…
This Phase III study, the administration of durvalumab + chemotherapy prior to surgery, followed by administration of durvalumab after surgery, will be investigated in patients with resectable Stages II and III NSCLC. The efficacy of durvalumab will…
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-…
• To assess which preoperative regimen provides superior event free survival 1 year after randomisation in patients with resectable gastric cancer
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…