This is a phase I, multi-center, open-label, multi-dose, two-part PK and safety study to characterize the DDI potential of oral Tazemetostat.
Primary Outcome Measures The probability of rejecting the investigational treatment is at least 81%, if the DLT rate is greater than 33% and the probability of accepting the treatment is at least 71% if the DLT rate is less than a safe level of 17%. [ Time Frame: up to 27 days ] Safety[…]
Primary Outcome Measures Dose-limiting toxicity （DLT） [ Time Frame: After 28 days of single infusion ] Safety Secondary Outcome Measures Maximum tolerated dose (MTD) [ Time Frame: After 28 days of single infusion ] Tolerability Objective response rate (ORR) [ Time Frame: Month 12 ] Clinical response will be assessed by RECIST 1.1. Progression-free survival (PFS) [ Time Frame: Month 12 ] PFS of patients receiving[…]
The primary objective is to evaluate the safety and tolerability of S-588210 (S-488210+S-488211) in patients with unresectable recurrent and/or metastatic solid tumors.
Study of SO-C101 and SO-C101in Combination With Pembro in Adult Patients With Advanced/Metastatic Solid Tumors
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
Heated Intra-peritoneal Chemotherapy With Doxorubicin and Cisplatin for the Treatment of Resectable, Refractory, or Recurrent Abdominal or Pelvic Tumors in Pediatric Patients, T.O.A.S.T. I.T. Study
This early phase I trial studies how well heated intra-peritoneal chemotherapy with doxorubicin and cisplatin work for the treatment of abdominal or pelvic tumors that can be removed by surgery (resectable), does not respond to treatment (refractory), or has come back (recurrent). Heated intra-peritoneal chemotherapy is a procedure performed in combination with abdominal surgery for cancer that has spread to the abdomen. It involves the infusion of a heated chemotherapy solution that circulates into the abdominal cavity. Drugs used in chemotherapy, such as doxorubicin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more cells.
This study will test whether giving nivolumab in combination with pemetrexed and either cisplatin or carboplatin before surgery is a safe and effective approach to treating resectable mesothelioma without delaying surgery.
A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17)
Primary Outcome Measures Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events (AEs), Version 5.0 (CTCAE) [ Time Frame: Up to 3 weeks ] DLTs will be assessed during the first cycle (21 days) and are defined as Grade (Gr) 4 hematologic toxicities (any period), except neutropenia[…]
This is a two phase study, The first phase (phase 1) will identify potential biomarkers among asbestos exposed individuals with pleural mesothelioma. The second phase (phase 2), is a double blinded case-matched controlled study to determine the predictive capability, sensitivity, and specificity of these biomarkers in detecting early stage pleural mesothelioma. Biomarkers in the form of volatile organic compounds (VOC) in exhaled breath samples from subjects with either pleural mesothelioma or pleural plaques, will be evaluated. A biomarker present in serum will also be concurrently evaluated in the same cohort. The soluble serum biomarker mesothelin related peptides (SMRP), which has been posited as a biomarker for mesothelioma, will be analyzed for its relationship to the breath VOC profile.
A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection (SMARTER)
Primary Outcome Measures Maximum Tolerated Dose for Background Radiation [ Time Frame: Up to five years ]AEs will be graded by CTCAE. Maximum tolerated dose is the dose level that do not result in fatal lung injury (grade 5 lung toxicity) or life-threatening or fatal treatment related toxicity (grade 4+). Secondary Outcome Measures Patient[…]