Clinical trials: Gastrointestinal Tract
Advanced Solid Tumors, MSI-H/dMMR Tumors
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
- Conditions
- Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC
- Trial name
- NCT04272034
- Testing
- INCB099318
- Where
- 24 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Incyte Corporation
Preeclampsia, Hypertension
Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S.
- Conditions
- Preeclampsia, Hypertension, Proteinuria, Thrombocytopenia
- Trial name
- NCT02780414
- Where
- 20 sites in United States
- Volunteers
- 1,730 people
- Sponsor
- Progenity, Inc.
Primary Biliary Cirrhosis
An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis
Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.
- Trial name
- CASCADE (NCT02321306)
- Testing
- LUM001
- Where
- 18 sites in United States, United Kingdom
- Sponsor
- Mirum Pharmaceuticals, Inc.
Lung Diseases, Liver Diseases
Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures
To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.
- Trial name
- ASNG (NCT01148706)
- Testing
- ActiSight Needle Guidance System
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- ActiViews Ltd.
Advanced Cancer, Metastatic Cancer
A Study of Merestinib (LY2801653) in Japanese Participants With Advanced or Metastatic Cancer
The main purpose of this study is to evaluate tolerability of merestinib monotherapy or in combination with other anti-cancer agents in Japanese participants with advanced and/or metastatic cancer.
- Conditions
- Advanced Cancer, Metastatic Cancer, Biliary Tract Carcinoma, Cholangiocarcinoma
- Trial name
- NCT03027284
- Testing
- Merestinib, Cisplatin, Gemcitabine
- Where
- 2 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Eli Lilly and Company
Alpha1-Antitrypsin Deficiency
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC…
- Trial name
- NCT04722887
- Testing
- Alpha-1 15%, Liquid Alpha1-Proteinase Inhibitor (Human)
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Grifols Therapeutics LLC
Alpha 1-Antitrypsin Deficiency
Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)
The purpose of this study is to evaluate the effects of weekly augmentation therapy with ARALAST Fraction IV-1 (Fr IV-1) on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor levels and other ELF analytes and to assess…
- Trial name
- NCT00396006
- Testing
- Alpha1-Proteinase Inhibitor
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 21 people
- Sponsor
- Baxalta now part of Shire
Healthy
BG00012 Regional Absorption Study
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying…
- Trial name
- NCT01924832
- Testing
- dimethyl fumarate
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Alpha 1-Antitrypsin Deficiency
Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)
The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT…
- Trial name
- NCT00263887
- Testing
- Alpha1-Proteinase Inhibitor (Human), Albumin (Human) 20%, United States Pharmacopeia (USP)
- Where
- 3 sites in Denmark, Sweden and 1 more
- Volunteers
- 77 people
- Sponsor
- Grifols Therapeutics LLC
Diphtheria, Tetanus
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00313911
- Testing
- DTaP-IPV-HB-PRP~T, Tritanrix-HepB/Hib
- Where
- 2 sites in Mexico, Peru
- Volunteers
- 2,133 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma
Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)
This is a first-in-human, Phase 1/2, open-label, dose escalation and dose expansion and combination study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Spevatamig…
- Conditions
- Gastric or Gastroesophageal Junction Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC), Colorectal Cancer
- Trial name
- NCT05482893
- Testing
- Spevatamig (PT886), Paclitaxel, Gemcitabine
- Where
- 11 sites in United States
- Volunteers
- 350 people
- Sponsor
- Phanes Therapeutics
Cystic Fibrosis
Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
This was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled Alpha-1 HC administered once a day for three weeks in subjects aged 18 years and…
- Trial name
- NCT01684410
- Testing
- Alpha-1 HC 100 mg, Alpha-1 HC 200 mg
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Grifols Therapeutics LLC
Cystic Fibrosis
PK Study of N91115 in Cystic Fibrosis Patients
This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to identify an initial starting dose for Phase…
- Trial name
- SNO3 (NCT02227888)
- Testing
- N91115
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Nivalis Therapeutics, Inc.
Neoplasm Malignant, Breast Cancer
Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
Primary Objectives: Part 1 (Dose Escalation) To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for…
- Conditions
- Neoplasm Malignant, Breast Cancer, Lung Neoplasm Malignant, Gastric Cancer
- Trial name
- NCT05013554
- Testing
- SAR443216 IV, SAR443216 SC
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 44 people
- Sponsor
- Sanofi
Cystic Fibrosis, Bronchiectasis
Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis
This is a single center, open label, Phase IIa, multiple-ascending dose study in which subjects with mild to moderate Cystic Fibrosis and non CF bronchiectasis (n≤12) will be enrolled.
- Trial name
- NCT03903913
- Testing
- S-1226
- Where
- 3 sites in Canada
- Volunteers
- 12 people
- Sponsor
- SolAeroMed Inc.
Carcinoma of Intrahepatic and Extra-hepatic Biliary System, Carcinoma of Gallbladder
Study of DKN-01 and Gemcitabine/Cisplatin in Patients With Carcinoma to Primary to the Intra- or Extra-Hepatic Biliary System or Gallbladder
DKN-01 is a humanized monoclonal antibody (Mab) with neutralizing activity against Dkk-1 and is being developed as an anti-neoplastic agent.
- Conditions
- Carcinoma of Intrahepatic and Extra-hepatic Biliary System, Carcinoma of Gallbladder, Bile Duct Cancer, Cholangiocarcinoma
- Trial name
- NCT02375880
- Testing
- DKN-01, gemcitabine, cisplatin
- Where
- 9 sites in United States
- Volunteers
- 51 people
- Sponsor
- Leap Therapeutics, Inc.
Advanced Solid Tumor, Cholangiocarcinoma
Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Cholangiocarcinoma, HER2-negative Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT04742959
- Testing
- TT-00420, Nab-Paclitaxel
- Where
- 6 sites in United States
- Volunteers
- 203 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Focus of the Study is on Gut Health
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods.
- Trial name
- NCT01518088
- Testing
- Dietary Fiber
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ingredion Incorporated
Cutaneous Melanoma, Non-small Cell Lung Cancer
A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug.
- Conditions
- Cutaneous Melanoma, Non-small Cell Lung Cancer, Colorectal Neoplasms, Pancreatic Neoplasms
- Trial name
- NCT05571839
- Testing
- PF-08046049
- Where
- 37 sites in United States, Canada and 4 more
- Volunteers
- 41 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Gut Health, Gastrointestinal Health
A Clinical Trial to Evaluate the Effects of a Chickpea Pasta on Gut Health, Blood Glucose, and Overall Health
This is a single-arm, 12-week pilot study evaluating the effects of a chickpea pasta on gut microbiome diversity, gastrointestinal health, and blood biomarkers.
- Trial name
- NCT07264465
- Testing
- Chickpea Pasta
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Banza LLC
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