Rapid Motion-Robust and Easy-to-Use Dynamic Contrast-Enhanced MRI for Liver Perfusion Quantification (Non-treatment cohort)
We propose to develop new rapid MRI techniques combining novel motion-robust sampling strategies and advanced reconstruction models to address these challenges.
A Multi-Center Prospective Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients with Ulcerative Colitis (ENDEAVOUR-UC)
The purpose of this research study is to observe the effectiveness of Etrasimod (Velsipity®) in adults with moderately to severely active ulcerative colitis (UC). The study consists of 52-weeks of follow-up from etrasimod initiation and an additional 28-day safety follow-up period.
A Phase 1 Study of the Polymerase Theta Inhibitor Novobiocin in BRCA-Mutant and Other DNA Damage Repair-Deficient Solid Tumors
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of novobiocin administered on a 5-days on/2-days off schedule in patients with solid tumors carrying homologous recombination (HR) or DNA damage repair (DDR) alterations that are PARP inhibitor- naïve or -resistant. Standard hematological and non-hematologic parameters, scored using CTCAE v.5.0, will be used to define dose-limiting toxicity (DLT).
ComboMATCH Treatment Trial E5: A Randomized Phase II Study of AMG 510 (Sotorasib) with or without Panitumumab in Advanced Solid Tumors
This study will have two groups of patients to test the combination of AMG 510 (Sotorasib) and panitumumab for advanced cancers with KRAS G12C mutations. Group 1 is a randomized phase II trial for patients with advanced solid tumors (except lung and colorectal cancer) who haven’t had treatment with a KRAS G12C inhibitor before. Patients will be randomly assigned to either AMG 510 alone or AMG 510 combined with panitumumab, with AMG 510 given at 960 mg once a day and panitumumab at 6 mg/kg every two weeks. Group 2 is for patients who have already used a KRAS G12C inhibitor and had their cancer progress. Patients in this group can have any type of tumor, including lung or colon cancer. Treatment will continue until the cancer grows or the side effects become too severe, and tumors will be checked every 8 weeks. The main goal of the study is to measure how well the treatment works by looking at the response rate.
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)
In this study, patients will fill out Health-Related Quality of Life (HRQoL) questionnaires when they visit the hospital for their scheduled appointments. These questionnaires will follow the EORTC guidelines. The main copies will be sent to the hospitals, and if more copies or translations are needed, they can be requested from the EORTC contact person. Clinical report forms will ask if the HRQoL questionnaires were completed, and if they weren't, the reasons will be noted. Patients will receive the questionnaires from the doctor or a study nurse before their check-ups, and they should complete them on their own in their own language during the visit. A designated person, like a research nurse, will help make sure that patients fill out the questionnaires correctly and completely. The study will check how well patients follow through with completing the questionnaires at each visit, and this will be reviewed every six months and included in reports.
A single arm phase II study of ADjuvant Endocrine therapy subcutaneous Pertuzumab and Trastuzumab fixed-dose combination for patients with anatomic stage I hormone receptor-positive HER2-positive breast cancer (ADEPT)
This is a single arm open-label phase II trial of adjuvant Fixed Dose Combination (FDC) of subcutaneous (SC) trastuzumab (H) plus pertuzumab (P) and endocrine therapy without chemotherapy in patients with stage I hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer. The primary endpoint is invasive disease-free survival when treated with a "de-escalated" regimen of hormonal and dual HER2-targeted therapy, with omission of a chemotherapy backbone. Eligible patients will have anatomic stage I (according to AJCC 8th edition anatomic staging table), HR+ and HER2+ breast cancer. HER2 positivity will be confirmed by central testing in all patients. Patients may be either pre- or post-menopausal. Patients must be naïve to systemic therapy for this cancer and have undergone primary breast surgery, with surgical pathology demonstrating stage I disease. After completion of primary breast surgery, patients will be registered to the trial, and receive adjuvant subcutaneous trastuzumab and pertuzumab (1 year), and hormonal therapy (at least 5 years). Patients will also receive adjuvant radiation therapy if deemed necessary per institutional practice. Patients will be followed for a total of 10 years for long-term disease outcomes. Patients will also participate in quality of life (QOL) surveys and symptom questionnaires at various time points through the course of study treatment and during follow-up. A subset of patients will participate in a single arm crossover substudy during four cycles of their overall therapy to receive two cycles of IV infusion followed by two cycles of SC FDC administration of HP, to specifically evaluate time and motion endpoints related to IV versus SC administration. Lastly, this study requires submission of tumor blocks or slides in order to perform biomarker analyses as well as blood draws for correlative analyses.
DAY101-001/PNOC026/FIREFLY-1: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with RAF-Altered Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors
DAY101 is an oral, selective, small-molecule, Type II pan-RAF kinase inhibitor that is being developed by DOT Therapeutics-1 Inc. (Day One, the Sponsor) for the treatment of recurrent or progressive pediatric low-grade gliomas and pediatric and adult solid tumors which harbor a known or expected to be activating RAF alteration.
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DAY101-002; LOGGIC/FIREFLY-2: A Phase 3 Randomized International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy.
The study is also being done to learn more about how the study drug is absorbed (taken up in the body), metabolized (broken down by the body), distributed (circulated in the body), and eliminated (passed out of the body). The patients will be monitored and taken care of while on these medication during the entire study period.
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