130 results
Primary Objective: To compare Overall Survival (OS) of subjects with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and…
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
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…
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 Objective* To compare the objective response rate and overall survival of BMS-936558 to investigator*s choice in subjects with advanced melanoma.Secondary Objectives* To compare the progression-free survival (PFS) of BMS-936558 to…
This study is designed as an extension to other veliparib clinical studies. The primary objective of thisstudy is to evaluate the safety and tolerability of veliparib monotherapy, veliparib in combination withcarboplatin/paclitaxel, or veliparib in…
2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…
PRIMARY OBJECTIVES Part I - To evaluate the efficacy (as measured by PFS) of GDC-0941 340 mg +carboplatin * paclitaxel (Arm A) versus carboplatin * paclitaxel (Arm B) in all patients with squamous NSCLC -To evaluate the efficacy (as measured by PFS…
The objective of this pilot study is to investigate the feasibility of using the Clip system in a human setting in creating an intracranial arteriotomy in a non-occlusive, sutureless fashion. Although the focus is on the technical success of the…
Primary goal is the evaluation of the safety and tolerability of MMMAE-anti-CD79b-conjugate administered every 3 weeks. The maximal tolerated dose and the dose-limiting toxicity are the important parameters. Based on these data, the dose of MMAE-…
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…
The final aim of the research project is to investigate the optimal time (*window*) for vaccination after chemotherapy.• To explore the optimal time-window to start immunotherapy after chemotherapy;• To study the time-related immune response to…
This study will evaluate the efficacy and safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). This study will compare the effects of 24 weeks of infusions of BMN 110 at…
The primairy objective of the trial is to determine the efficacy of BIBW 2992 plus weekly paclitaxel compared to the investigators choise of chemotherapy alone in patients with NSCLC stage IIIb or IV progressing after experiencing a benefit from…
Primary objective:* To determine the safety, tolerability, dose-limiting toxicities (DLT), maximum acceptable dose (MAD) and maximum tolerated dose (MTD) of CHR-2845 when administered orally to patients with advanced or treatment refractory…
The objectives are to evaluate the safety and efficacy of TRC4186 and to define the recommended dose level for further pivotal studies.
A consistent finding in many studies in patients with operable esophageal and gastro-esophageal junction (GEJ) cancer is that response to preoperative therapy, particularly the absence of residual disease in the surgical specimen, is an indicator of…
Primary Objective:To assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of…
Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.
To compare the effect of paclitaxel plus MORAb-003 to paclitaxel plus placebo on progression free survival (PFS) as determined by RECIST in subjects who are in a first platinum-resistant or refractory relapse of ovarian cancer.