View clinical trials related to Neoplasms.
Filter by:The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
Subjects with locally advanced or metastatic incurable Tumor Infiltrating Lymphocytes (TIL)-negative solid tumors who are not eligible for, declined or failed standard therapy will be treated with a combination nivolumab, low-dose ionizing radiation (RT) (0.5-2 Gy), aspirin (ASA)(cohorts 1 and 2)/celecoxib (cohorts 3, 4 and Phase Ib), and either ipilimumab or low-dose cyclophosphamide. The study comprises 2 phases: The aim of Phase Ia, is to determine safety and tolerability of a given combination therapy, as well as the maximum tolerated dose (MTD) or recommended phase Ib dose (RP1bD) of radiotherapy. Phase Ib aims to further explore safety and tolerability of this treatment in an expansion cohort. In Phase Ia, 4 distinct cohorts will receive the following combination therapy: Cohort1: combination therapy for 5 cycles (C0-C4) which includes: RT 0.5 Gy every 2 weeks (Q2W), Cy (200 mg/m2) Q2W (cycles C0 to C4); ASA (300 mg) daily, with nivolumab 240 mg flat dose Q2W and ipilimumab 1 mg/kg every 6 weeks (Q6W) will be administered (cycles C1 to C4). Cohort2: combination therapy for 5 cycles (C0-C4) which includes: RT 1 Gy every 2 weeks (Q2W), Cy (200 mg/m2) Q2W (cycles C0 to C4); ASA (300 mg) daily, with nivolumab 240 mg flat dose Q2W and ipilimumab 1 mg/kg (Q6W) will be administered (cycles C1 to C4). Cohorts 3a and 4a: Patients will receive Cy (200 mg/m2) Q2W, celecoxib (2x200mg daily), nivolumab (240 mg flat dose) Q2W, and low-dose radiation. Cohort 3a will receive 1 Gy of low-radiation dose and cohort 4a will receive 2 Gy. Cohorts 3b and 4b: Patients will receive nivolumab (240 mg flat dose) Q2W, ipilimumab 1 mg/kg (Q6W), celecoxib (2x200mg daily) and low-dose radiation. Cohort 3b will receive 1 Gy of low-radiation dose and cohort 4b will receive 2 Gy. In Phase Ia, the safety of combination (nivolumab, celecoxib, low-dose irradiation and cyclophosphamide) or (nivolumab, celecoxib, low-dose irradiation and ipilimumab) will be evaluated , and MTD or RP1bD will be defined. RP1bD will be the MTD or, in the absence of dose limiting toxicities (DLTs), the biologically best RT dose based on pharmacodynamics parameters. In Phase Ib, patients will be treated with the MTD or RP1bD dose of RT and will follow the selected schema of treatment used in the Phase Ia cohort 3 or 4. At the end of the 5th cycle, patients eligible for nivolumab maintenance, will be treated with nivolumab at 240 mg Q2W until progression or excessive toxicity; celecoxib will be maintained according to tolerability.
This study was a four-group randomized pilot trial in myeloproliferative neoplasm (MPN) patients. Patients were recruited nationally through organizational partners and social media. Eligible and consented patients were enrolled into one of four groups, two of which received varying orders of two consumer-based apps (unnamed consumer-based [CB] app and Calm App) and two that received one of the apps alone for the second four weeks of the eight week intervention after an educational control condition. Participants were asked to perform 10 min/day of smartphone-based meditation irrespective of the app and/or the order in which they received the apps. Feasibility outcomes were measured at week five and nine with an online survey. Feasibility outcomes were acceptability, demand, and limited efficacy for depression, anxiety, pain intensity, sleep disturbance, sexual function, quality of life, global health, and total symptom burden. The purpose of this study was to examine the feasibility of the use of two different consumer-based meditation smartphone applications (i.e., apps) in MPN patients. Specific aim #1: Examine the feasibility of daily meditation delivered using a consumer-based mobile app. Hypothesis: It will feasible to deliver smartphone-based meditation to MPN patients. Exploratory Aim: Explore the preliminary effects of daily meditation delivered using a consumer-based mobile app on MPN self-report fatigue, anxiety, depression, pain intensity, sleep disturbance, sexual function, global health, quality of life, and total symptom burden. Hypothesis: There will be demonstrated preliminary effects on patient-reported outcomes in MPN patients.
NBM-BMX is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by NatureWise. NBM-BMX is a histone deacetylase (HDAC) inhibitor and has been shown to be particularly active against HDAC8. The objectives of this study are to determine the safety profile of NBM-BMX, including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and to determine the Recommended Phase 2 Dose (RP2D).
The main purpose of the study is to evaluate a safe, tolerable recommended Phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of M3814 when given in combination with avelumab with and without radiotherapy in participants with selected advanced solid tumors.
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.
The investigators hypothesized that with the administration of the nutritional supplement Ocoxin-Viusid® is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients diagnosed with advanced pancreatic adenocarcinoma, treated at the "Hermanos Ameijeiras" Surgical Clinical Hospital. Phase II clinical trial, open, multicenter, nonrandomized.
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies.
TP-3654 is an oral PIM inhibitor. This is a Phase 1, open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-3654 in patients with advanced solid tumors.
To investigate the safety and tolerability of GLS-010 in subjects with advanced solid tumors (mainly gastric cancer, esophageal cancer). To investigate the preliminary relationship between the expression of the ligand of PD-1 (PD-L1) and efficacy.