16 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 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 this study is:To determine the response rate [the combined complete response (CR) + partial response (PR) + minimal response (MR)] following treatment with BDR in patients with previously untreated WM.Secondary objectives…
The primary objective of this study is to compare, in a randomized phase III trial, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (*3+7*) on OS in older AML patients.
PRIMARY OBJECTIVESThe primary objective of MAKEI V is to assess in a randomized comparison whether the efficacy of Carboplatin (600 mg/m² per cycle) (AUC 7.9 mg/ml/min.) is not inferior to Cisplatin (100 mg/m² per cycle) in malignant GCT (MGCT) of…
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…
The aim of this study is to reduce the indication for RT without compromising cure rates. To investigate if intensified consolidation therapy (DECOPDAC-21) compared to standard consolidation therapy (COPDAC-28) can compensate for reduction in RT.
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 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…
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,…
Primary: • To investigate whether adjuvant atezolizumab treatment after standard, concurrent chemo-radiotherapy improves overall survival (OS) compared with no treatment after standard, concurrent chemo-radiotherapy in limited disease SCLC patients.…
The objective of the induction/consolidation chemotherapy randomisation (R1) is to compare: - VIDE strategy: vincristine, ifosfamide, doxorubicin and etoposide (VIDE) as induction chemotherapy and vincristine, actinomycin D and ifosfamide (VAI),…
To investigate wether the treatment of children and adolescents with AML can be improvedby means of:1) improved risk-group adapted treatment2) reduced treatment toxicity through shortened consolidation therapy.
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-…
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…
To compare two (standard) treatment regimens in patients with KRAS mutated advanced stage NSCLC as first line treatment.