The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test in the laboratory may help the study of cancer.
To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies
To determine the safety and tolerability of docetaxel as Oradoxel
To determine the incidence of unacceptable toxicity with Oradoxel
To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel
To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel
To evaluate tumor response
To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies
To determine the recommended Phase 2 dose of paclitaxel as Oraxol
To determine the safety and tolerability of paclitaxel as Oraxol
To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol
To evaluate the tumor response
While radiation is an essential component to the treatment of glioblastoma, it's use is limited due to toxicity when higher doses are attempted. Rhenium is a compound which releases radiation in small particles that are absorbed after only a fraction of an inch. This limited penetration means that high doses potentially can be given without the toxicity of other forms of radiation. In order for the radiation to be retained within the tumor, it has been packaged in microscopic fat-like particles termed nanoliposomes. These facilitate the uptake of the radiation particles by the tumor. In order to better characterize this form of radiation therapy, it is being administered in patients who have failed other forms of therapy for glioblastoma. The treatment is administered by tubing inserted into the center of the tumor in the operating room. There are two portions to this study. The first involves progressively increasing doses until the most tolerable dose can be identified. The second portion of the study involves a larger number of patients being treated at the determined most tolerable dose to better evaluate how well the treatment works.
To demonstrate the non-inferiority of a single IV dose of fosnetupitant/palonosetron (260 mg/0.25 mg) combination (IV NEPA FDC) administered as a 30-minute IV infusion with oral dexamethasone on Day 1 versus a single oral dose of netupitant/palonosetron (300 mg/0.5 mg) combination (oral NEPA FDC) administered as one capsule with oral dexamethasone on Day 1, in terms of proportion of patients with complete response (CR, defined as no emetic
episodes and no rescue medication) in the overall phase (0-120 hours after start of AC chemotherapy).