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We list hundreds of Clinical Trials about "PRE-DETERMINE Cohort Study" on BioPortfolio. We draw our references from global clinical trials data listed on ClinicalTrials.gov and refresh our database daily.
We have published hundreds of PRE-DETERMINE Cohort Study news stories on BioPortfolio along with dozens of PRE-DETERMINE Cohort Study Clinical Trials and PubMed Articles about PRE-DETERMINE Cohort Study for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of PRE-DETERMINE Cohort Study Companies in our database. You can also find out about relevant PRE-DETERMINE Cohort Study Drugs and Medications on this site too.
Objectives: Primary: To determine if targeted therapy + atezolizumab (cohorts 1-3) will lead to improved overall survival (OS) in patients with anaplastic thyroid carcinoma (ATC). Secondary: 1. To evaluate the safety and efficacy (RECIST response rate, progression-free survival [PFS]) of targeted therapy + atezolizumab (cohorts 1-3) in ATC and poorly differentiated thyroid cancer (PDTC). 2. To determine the OS in patients with PDTC treated w...
The purpose of this study is to evaluate primarily the safety and tolerability and secondarily the efficacy of topically applied WBI-1001 cream in patients with mild to moderate psoriasis. Double-blind, randomized, placebo controlled study of 36 patients, treated for 28 days plus a 7 day follow-up.in which the patients were divided into six cohorts: Cohort 1 at 0.5% QD;Cohort 2 at 0.5% BID; Cohort 3 at 1.0% QD; Cohort 4 at 1.0% BID; Cohort 5 at 2.0% QD; Cohort 6 at 2.0% BID.Eff...
This is a single arm, open-label phase Ib study of combining eribulin mesylate with avelumab. The initial 9-12 patients (MTD cohort) will be enrolled to determine safety of avelumab in combination with eribulin mesylate. Upon determination of maximum tolerated dose (MTD), 12 additional patients will be enrolled in an expansion cohort (efficacy cohort) to determine ORR at 6 months.
A Phase 1, Open Label, Parallel-Cohort, Randomized, Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between PF-04965842 and Fkuvoxamine (cohort 1) or Fluconazole (Cohort 2) in healthy subjects.
This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to determine the maximum tolerated dose of CC-220 when administered as monotherapy and in combination with dexamethasone. The study will consist of an escalating dose-escalation portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: MonoT and Cohort D: DoubleT) at the recommended Phase 2 dose (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).
This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946 in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel. The trial will involve multiple participating sites from the US. Following determination of the MTD, an expansion cohort of 20 evaluable subjects with breast cancer was planned. Finally, 16 patients have been enrolled t...
This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in comparison with that of vehicle in patients with Basal Cell Carcinoma. One investigational center (metasite) in the United States will participate in this study. Approximately 36 subjects who meet the study entry criteria will be enrolled into one of four sequential cohorts. Within each cohort subject...
This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Per cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64 years and 65-75 years) with a minimum...
Study consists of 6 treatment cohorts of 12 subjects with chronic pain, OBD and opioid physical dependence. Total duration of treatment for each subject will be up to 28-days. Each subject will receive single dose of study drug, administered orally. Cohort 1: 0.1 mg of S-297995 or placebo. Cohort 2: 0.3 mg of S-297995 or placebo. Cohort 3: 1 mg of S-297995 or placebo. Cohort 4: 3 mg of S-297995 or placebo. Cohort 5: 6 mg of S-297995 or placebo. Cohort 6: 10 mg of S-297995 or ...
Study is a dose escalation study. Fifteen patients will be enrolled in 2 treatment cohorts. Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2 weeks, off 2 weeks, then again 5 days/week for 2 weeks. If no serious adverse events are noted in cohort A patients, ten participants will be treated in cohort B. Cohort B participants will be treated the same as cohort A participants except that dose will be increased to 400IU Multikine per day.
This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single subcutaneous injection. Subjects will remain confined at the research clinic for approximately 2 days. After discharge, subjects will return to the research clinic 15 times during 12 weeks.
Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib. In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single agent and in combination with chemotherapy in patients with relapsed/refractory neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I 3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6 patients (Cohort B1), within ...
This multi-cohort phase I study is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of oxytocin and to evaluate epelsiban (GSK557296) potential to reduce subendometrial contractractility induced by oxytocin in healthy female subjects. Additionally tissues concentrations of epelsiban will be determined from endometrial tissue biopsies. Data from this study will inform the identification of the doses of epelsiban to be used in future in-vitro fertilization (...
This study will enroll subjects with previously untreated CLL/SLL into two cohorts (Cohort 1 without del[17p] and Cohort 2 with del[17p]). Cohort 1 subjects will receive either "BGB-3111 alone" or "bendamustine (B) and rituximab (R)". Cohort 2 subjects will receive BGB-3111 alone. The primary purpose is to evaluate the efficacy and safety of BGB-3111 versus bendamustine and rituximab in Cohort 1.
The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer. This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose de-escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (...
The purpose of this first in human study is to determine the safety and feasibility of 1RG-CART therapy in patients with relapsed or refractory neuroblastoma. 1RG-CART therapy is a novel immunotherapy under investigation immunotherapeutic approach in which patients have their T-cells (a type of white blood cell) collected and modified in the laboratory, before they are given back to the patient. The T-cells are modified to express a chimeric antigen receptor (CAR) which targets...
This study is a multi-cohort, open-label, multicenter Phase 2 study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1) and in subjects with HR MM having progressed within one year of initial treatment (Cohort 2). Approximately 122 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2 will enroll approximately 49 MM subje...
This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.
The purpose of this study is to identify the the optimum effective dose, dose limiting toxicity and maximum tolerated dose of SM88.
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be three cohorts in this study with 70 participants enrolled in each cohort: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, and Cohort C will receive pembrolizumab + enzalutamide. Outcome measures will be assessed individually...
This is a single-arm open label trial to explore the tolerability, safety, PK, PD, and anti-tumor activity of various doses and schedules of CHO-H01 administered as monotherapy in subjects with follicular lymphoma. Groups of 6 subjects are planned for each cohort. The first 3 patients of each cohort will be evaluated to determine if it is appropriate to proceed with the additional 3 patients at that dose and schedule.
This cohort study will establish the urban elderly cohort, measure both physical and functional parameters, find the risk factors for aging, and validate the role of strength training for those sarcopenic patients. We hope this study will be widely cited in related fields in the future.
This is a phase 1, randomized, partially-blind, parallel group, active and placebo controlled study to evaluate the PK and safety of single oral doses of ETV XR tablet in healthy subjects. Approximately 40 healthy volunteers will be enrolled in this study. Eligible subjects will be randomized 1:1:1:1:1 to the following treatment groups, respectively: - Cohort 1 (Blinded): 1.5 mg ETV XR tablet - Cohort 2 (Blinded): 3 mg ETV XR tablet - Cohort 3 (Blinded)...
With the development of population aging, the incidence of covert stroke and cognitive dysfunction gradually increased. Currently, there is still lack of prospective cohort study with large sample size on the relationship between perioperative covert stroke and postoperative cognitive dysfunction. The investigators will perform a prospective cohort study. The aim of the study is to determine whether there is an association between perioperative covert stroke and postoperative c...
This is a phase I, randomized, safety and pharmacokinetic (PK) study of sorafenib given in combination with capecitabine. The study will enroll two simultaneous cohorts; patients will be randomly assigned to either Cohort A or Cohort B. A third cohort (C) may be added to the protocol at a later date.