16 results
MAIN OBJECTIVESDose escalation study:To establish the safe use of trastuzumab (Synthon BV, the Netherlands) in healthy volunteers at different dose levels up to 6 mg/kg.Bioequivalence study:Demonstrate bioequivalence between trastuzumab (Synthon BV…
To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine iv chemotherapy as treatment in patients with HER2-overexpressing, metastatic breastcancer, who failed one prior trastuzumab treatment.
Primary: To estimate the MTD or RDE and preferred dosing schedule of LJM716 when administered in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer or gastric cancer.Secondary: Safety and tolerability, PK, PD…
Pertuzumab is the investigational agent being studied for the treatment of HER2-positive gastric cancer. This study is to compare the overall survival (OS) in patients treated with pertuzumab in addition to trastuzumab (Herceptin®) plus cisplatin…
To compare progression-free survival (PFS) between the two treatment arms based on assessments by an independent review facility (IRF).
The main objectives are to evaluate the efficacy (as measured byprogression free survival at 6 months) of pertuzumab combined withtrastuzumab (PH) or PH plus metronomic chemotherapy (PHM) in anelderly metastatic breast cancer population, and to…
Primary ObjectivesPart A: RO6874281 Dose Escalation as a Single AgentThe primary objectives for this study are as follows:* To describe the safety and tolerability profile of RO6874281 as a single agent* To determine the maximum tolerated dose (MTD…
The primary objective is to determine if metastatic breast cancer patients with HER2-negative primary tumors but with at least one HER2-positive CTC benefit from trastuzumab-containing chemotherapy. Secondary objectives are to determine the impact…
Primary Objective:The primary objective of this study is to evaluate the efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared to trastuzumab…
Assess the feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery
Primary objectivesThe primary objective of this trial is to evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inbibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line…
To evaluate the efficacy and pharmacodynamics (PD) of ELX/TEZ/IVA
To determine the activity (as measured by objective response rate by RECIST1.1) of monalizumab and trastuzumab in patients with metastatic HER2-positive breast cancer.
To evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF subjects with impaired glucose tolerance (IGT) or CF related diabetes (CFRD)
To evaluate the efficacy of VX-121/TEZ/D-IVA in CF subjects who are homozygous forF508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, orhave at least 1 other TCR CFTR mutation and no F508del mutation
Primair eindpunt:Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Homozygous or Heterozygous for the F508del Mutation.Secundair eindpunt:Evaluate the long-term efficacy of VX-…