24 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…
To determine if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by overall survival.
To investigate if concomitant and adjuvant temozolomide chemotherapy improves survival in elderly patients that are managed with a short course of radiotherapy.
The primary objective of the study is to assess the progression-free survival (PFS) of oralveliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel.The…
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…
Primary objective:To evaluate the single- and multiple-dose safety and pharmacokinetics of CNM-Au8 upon oral administration of CNM-Au8 to healthy adult male and female subjects.Secondary objective:Exploreing the immune-modulating effects of CNM-Au8…
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…
This study will investigate whether treatment with Nivolumab in combination with radiation therapy, is comparable to Temozolomide in combination with radiation therapy in patients with Unmethylated MGMT Glioblastoma. We will measure this by…
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 determine the best treatment for anaplastich oligodendroglial tumors with combined 1p/19q loss, and to determine the optimal treatment with respect to the maintenance of a maximal neurological and cognitive functioning.
Determine whether early postoperative treatment results in a longer survival without further treatments and in the end a longer overall survival, and whether earlier treatment results in the earlier occurence of delayed adverse effects of treatment
This is a phase I study of hydroxyurea and dose-intense temozolomide in patients with recurrent glioblastoma that are elegise for re-challenge temozolomide.Primary Objective: To determine the maximal tolerated dose and safety profile of daily…
Main objective:The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. Thisevaluation will follow a…