Clinical trials: Biliary Tract
Uterine Neoplasms, Uterine Cervical Neoplasms
Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations
This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the…
- Conditions
- Uterine Neoplasms, Uterine Cervical Neoplasms, Biliary Tract Neoplasms, Urologic Neoplasms
- Trial name
- NCT04579380
- Testing
- tucatinib, trastuzumab, fulvestrant
- Where
- 108 sites in United States, Belgium and 6 more
- Volunteers
- 217 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Biliary Disease, Pancreatic Disease
Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes.
- Conditions
- Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction
- Trial name
- NCT05429203
- Testing
- Duodenoscope with single-use distal cover, Conventional duodenoscope
- Where
- United States
- Volunteers
- 319 people
- Sponsor
- Stanford University
Solid Tumors
Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer
In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in combination with gemcitabine.
- Trial name
- NCT02240238
- Testing
- NC-6004, Gemcitabine
- Where
- 22 sites in United States, Bulgaria and 3 more
- Volunteers
- 119 people
- Sponsor
- NanoCarrier Co., Ltd.
Cholestasis, Total Parenteral Nutrition-induced Cholestasis
Compassionate Use of Omegaven IV Fat Emulsion
This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct…
- Trial name
- NCT00816348
- Testing
- Omegaven
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Cindy Haller
Progressive Familial Intrahepatic Cholestasis (PFIC)
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
- Trial name
- NCT04185363
- Testing
- Maralixibat
- Where
- 28 sites in United States, Argentina and 14 more
- Volunteers
- 84 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8
Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body.
- Conditions
- Stage III Distal Bile Duct Cancer AJCC v8, Stage III Gallbladder Cancer AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Distal Bile Duct Cancer AJCC v8
- Trial name
- NCT03768414
- Testing
- Cisplatin, Gemcitabine Hydrochloride, Nab-paclitaxel
- Where
- 692 sites in United States
- Volunteers
- 452 people
- Sponsor
- SWOG Cancer Research Network
Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD).
- Conditions
- Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer, Ampulla of Vater Cancer
- Trial name
- NCT01134276
- Testing
- biliary drainage
- Where
- South Korea
- Volunteers
- 211 people
- Sponsor
- Seoul National University Hospital
Primary Biliary Cholangitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).
- Trial name
- PBC-Phase 2 (NCT02943447)
- Testing
- Cilofexor
- Where
- 25 sites in United States, Austria and 2 more
- Volunteers
- 71 people
- Sponsor
- Gilead Sciences
Biliary Tract Neoplasms
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).
- Trial name
- TOPAZ-1 (NCT03875235)
- Testing
- Durvalumab
- Where
- 126 sites in United States, Argentina and 15 more
- Volunteers
- 810 people
- Sponsor
- AstraZeneca
Advanced Biliary Tract Cancer
NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer
This is a study to evaluate the clinical activity of the combination of fluorouracil, leucovorin, and nanoliposomal irinotecan as second-line treatment in patients with advanced biliary tract cancers following gemcitabine and…
- Trial name
- NCT04005339
- Testing
- Nanoliposomal Irinotecan, Leucovorin, Fluorouracil
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- Georgetown University
Primary Biliary Cirrhosis
Initial Study of Rituximab to Treat Primary Biliary Cirrhosis
The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT00364819
- Testing
- rituximab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, Davis
Primary Sclerosing Cholangitis (PSC)
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.
- Trial name
- NCT03333928
- Testing
- HTD1801
- Where
- 26 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Primary Sclerosing Cholangitis
Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis
This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT05642468
- Testing
- Ritivixibat
- Where
- 8 sites in France, Italy and 2 more
- Volunteers
- 18 people
- Sponsor
- Albireo, an Ipsen Company
Cancer
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC)…
- Trial name
- NCT02034110
- Testing
- Dabrafenib, Trametinib
- Where
- 41 sites in United States, Austria and 12 more
- Volunteers
- 206 people
- Sponsor
- Novartis Pharmaceuticals
Primary Biliary Cholangitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis
- Trial name
- NCT03394924
- Testing
- EDP-305 1 mg, EDP-305 2.5 mg
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 68 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Cervical Cancer, Endometrial Cancer
A Study of Patients Receiving High-Dose Rate Brachytherapy
Background: One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer…
- Conditions
- Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Prostate Cancer
- Trial name
- NCT00924027
- Testing
- High Dose Radiation (HDR) Brachytherapy, MRI, CT
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- National Cancer Institute (NCI)
Biliary Tract Cancer
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer
- Trial name
- NCT00380588
- Testing
- gemcitabine, cisplatin
- Where
- 7 sites in Japan
- Volunteers
- 84 people
- Sponsor
- Eli Lilly and Company
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Liver Cirrhosis, Biliary
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment…
- Trial name
- NCT03633227
- Testing
- Obeticholic Acid (OCA)
- Where
- 40 sites in United States, Argentina and 10 more
- Volunteers
- 22 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Tract Disease
Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS
This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy…
- Trial name
- SPYDS (NCT02524418)
- Testing
- Cholangiopancreatoscopy
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- University of Florida