Gastroenterología y Hepatología

A continuación, se enumeran los ensayos clínicos actuales.

Filtra esta lista de estudios por sede, estatus, etc.

1. Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients with Advanced Solid Tumors

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to demonstrate the safety and tolerability of JAB-3312 in combination with anti-PD-1 mAb or MEKi or KRASi or EGFR-TKI in patients with advanced solid tumors.

2. A Study to Evaluate Whether Probiotics for Gut Microbiome Will Target Cancer Immune Microenvironment in Breast and Lung Cancer

   Jacksonville, Fla.

   The purpose of this study is to evaluate whether engineering gut microbiome using probiotics will alter host immunological response to breast and lung cancers.

    

3. Study Analyzing Use of Mucosal Impedance in Evaluation of Gastroesophageal Reflux Disease

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to evaluate the accuracy of balloon catheter based mucosal impedance for the diagnosis of GERD in patients who have undergone Peroral Endoscopic Myotomy (POEM).

4. A Study to Detect Pancreatic Cancer Using Circulating Tumor Markers

   Rochester, Minn.

   The primary purpose of this study is to select and validate candidate methylated DNA markers (MDMs) (individually and in combined panels) for the detection of pancreative ductal adenocarcinoma (PDAC). The potential complementary value of mutant KRAS and CA19-9 will also be evaluated.

5. Futibatinib and Pembrolizumab for the Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer

   Rochester, Minn.

   This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression after receiving at least 1 line of therapy. Patients will receive futibatinib 20 mg daily Days 1-21 and will receive pembrolizumab 200 mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell free DNA and circulating tumor cells at baseline, after 3 and 6 cycles, and at progression. We will collect tumor biopsy specimens before treatment initiation to develop patient derived tumor organoid.

6. A Study to Evaluate Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   In our own data sequencing 3,000 patients with pancreatic cancer, approximately 3% of pancreatic cancer patients harbor germline mutations in DNA repair genes such as BRCA1/2 and PALB2, and are therefore potential candidates for PARP-inhibitor therapy. In addition, somatic mutations in Homologous Recombination Repair (HRR) genes can confer sensitivity as well, and have been reported to double the number of patients potentially eligible for such therapy. The Keynote-162 study of niraparib and pembrolizumab has validated this approach, with early reports of impressive efficacy. Although unselected trials in pancreatic cancer with immunotherapy alone have yet to be successful, we hypothesize that induced genetic variation with PARP inhibition disrupting the tumor microenvironment and increasing neoepitope expression can sensitize tumors to immune checkpoint inhibition. We have developed preliminary data with RNAseq suggesting that potent PARP inhibition is associated with gain of novel mutations in pancreas cell lines, even compared to cisplatin alone, or irinotecan alone. We propose that a combination of PARP inhibition and anti-PD1 therapy has valuable therapeutic potential in pancreatic cancer. HRR deficient pancreatic cancer has largely been defined to date based on mutations in well-established genes such as BRCA1/2 and PALB2. However, more DNA repair associated genes are becoming associated with risk for pancreatic cancer and may well impact tumor phenotype. The goal would be to evaluate the combination of niraparib and TSR-042 in patients with germline or somatic mutations in BRCA1/2 or PALB2.

7. A Study to Compare of the Glycotest™ HCC Panel vs AFP for the Detection of Early-stage Hepatocellular Carcinoma

   Rochester, Minn.

   The purpose of this study is to compare the use of the Glycotest HCC Panel vs. the serum protein biomarker alpha-fetoprotein (AFP) for the early detection of Hepatocellular Carcinoma (HCC).

8. A Study to Evaluate the Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

   Rochester, Minn.

   The purpose of this study is to understand why patients with indigestion, with or without diabetes, have gastrointestinal symptoms and, in particular, to understand where the symptoms are related to increased sensitivity to nutrients.Subsequently, look at the effects of Ondansetron on these patients' symptoms.

9. Improving the Quality of Care for Adults with Inflammatory Bowel Disease

   Jacksonville, Fla.

   The purpose of this study is to demonstrate the impact of an Adult Inflammatory Bowel Disease (IBD) learning health system approach that enables patients and their care teams to coproduce optimal health and high value care.

10. A Study to Measure Blood Vessel Health in Non-Pregnant Women

    Rochester, Minn.

    This study will allow us to determine normal values for the health of this gel-like layer in non-pregnant women. We will also determine whether values vary from day to day, in the same person. Normal responses from this study will be compared with data obtained in other studies (for example, studies of women who had the pregnancy complication preeclampsia, or women who have other risk factors for heart disease). This will help us to determine whether the glycocalyx contributes to the risk of preeclampsia and heart disease in women with different risk factors.