13 results
Primary Objective• For Arms A, B, and C: Determine the overall response rate (RR) of EZN-2208 for two distinct cohorts of patients with mCRC- Patients with mutated K-RAS tumors (Arm A)- Patients with wild-type K-RAS tumors (Arms B and C)• For Arms B…
Phase IIb: To evaluate the most effective dosing schedule of trabectedin.Phase III: To evaluate whether trabectedin given as 1st line chemothearpy for advanced/metastatic soft tissue sarcoma prolongs progression free surivival, as compared to…
Primary: To provide metastatic colorectal cancer patients with access to aflibercept and todocument the overall safety in these patientsSecondary: To document the Health-Related Quality of Life of aflibercept in this patientpopulation
The key objective of the study is to prove that trabectedin (Yondelis) and PLD prolong overall survival versus carboplatin + PLD, in patients with progressive ovarian cancer 6 to 12 months after completing previous platinum based chemotherapy.As…
The primary objective of this study is to evaluate the effects of SYR-322 and SYR-322coadministered with pioglitazone HC1 versus placebo on postprandial triglycerides in subjectswith type 2 diabetes.
This protocol is designed to determine the safety, tolerability, and efficacy of SGI-110 in combination with irinotecan in previously treated patients with metastatic colorectal cancer who progressed on irinotecan.
Phase A:Primary objective: Determining the feasibility of gemcitabine as a radiosensitizer in DIPG Secondary objective: Evaluation of efficacy in terms of clinical and radiological response rate and progression free survivalTertiary objectives:…
The objective of the study is to investigate whether trabectedin demonstrates sufficient antitumor activity against recurrent grade II or III to justify further investigation in phase III or as adjuvant therapy for newly diagnosed disease after…
Primary:1) To compare OS in subjects with squamous cell carcinoma of the Esophagus.2) To compare OS in subjects with PD-L1 Combined Positive Score (CPS)*10%3) To compare OS in all subjectsSecondary:1) To evaluate the progression free survival (PFS)…
To develop a dosing nomogram of irinotecan in patients homozygous polymorphic for UGT1A1*28 and/or UGT1A1*93 in order to reduce the incidence of severe irinotecan-associated toxicity, defined as febrile neutropenia during the first two cycle of…
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…
Main objective of this project is to establish the maximum tolerable dose (MTD) and recommended phase II dose of intraperitoneal irinotecan in patients with PC of colorectal origin, added to standard of care systemic chemotherapy. Other endpoints…
Primary Objective & HypothesisIn subjects with first line (1L) stage IV MSI-H or dMMR CRC treated with first line (1L) pembrolizumab (MK-3475) versus SOC chemotherapies,Objective: To compare Progression Free Survival (PFS) per RECIST 1.1 by…