Clinical trials: Biliary Tract Diseases
Advanced Solid Tumor, Cholangiocarcinoma
To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) 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 (solid tumor, BTC and…
- Conditions
- Advanced Solid Tumor, Cholangiocarcinoma, Biliary Tract Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05253053
- Testing
- TT-00420, Combination Product: Atezolizumab, Combination Product: Nab-Paclitaxel
- Where
- 9 sites in China
- Volunteers
- 84 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Advanced Gastrointestinal Tumors
Study of Minnelide™ in Patients With Advanced GI Tumors
The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol
- Trial name
- NCT01927965
- Testing
- Minnelide™ 001
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Minneamrita Therapeutics LLC
Biliary Tract Cancer, Gallbladder Cancer
Vandetanib Gemcitabine Or Placebo Plus Gemcitabine Or Vandetanib Monotherapy In Advanced Biliary Tract Cancer
The primary objective of the trial is to determine the efficacy of VANDETANIB monotherapy or VANDETANIB plus GEMCITABINE or PLACEBO plus GEMCITABINE in prolonging the progression-free survival (PFS) at the trial closure in…
- Conditions
- Biliary Tract Cancer, Gallbladder Cancer, Cancer Of The Extrahepatic Bile Duct, Ampullary Carcinoma
- Trial name
- VANGOGH (NCT00753675)
- Testing
- ZD6474, Vandetanib, Gemcitabine
- Where
- 15 sites in Italy
- Volunteers
- 174 people
- Sponsor
- Genzyme, a Sanofi Company
Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer), Pancreatic Ductal Adenocarcinoma (PDAC)
To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors
The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with…
- Conditions
- Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer), Pancreatic Ductal Adenocarcinoma (PDAC), Hepatocellular Carcinoma (HCC), Gastric Cancer (GC)
- Trial name
- NCT07594964
- Testing
- XH001 Injection, mFOLFIRINOX Treatment Regimen
- Where
- 2 sites in China
- Volunteers
- 48 people
- Sponsor
- Shenzhen Xinhe Biomedical
PFIC1, PFIC2
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC)…
- Trial name
- PEDFIC 1 (NCT03566238)
- Testing
- A4250 (odevixibat)
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 62 people
- Sponsor
- Albireo
Biliary Tract Cancer
A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients
This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs.
- Trial name
- NCT03873532
- Testing
- Surufatinib, Capecitabine
- Where
- China
- Volunteers
- 298 people
- Sponsor
- Hutchison Medipharma Limited
Hepatocellular Carcinoma, Renal Cell Carcinoma
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
This is a research study of an experimental drug called ACC-1898. ACC-1898 is an oral tyrosine kinase inhibitor (TKI) that blocks several proteins kinases which may help cancer cells grow and spread.
- Conditions
- Hepatocellular Carcinoma, Renal Cell Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Carcinoma Primary Differentiated
- Trial name
- NCT07252661
- Testing
- ACC-1898
- Volunteers
- 40 people
- Sponsor
- AccSalus Biosciences, Inc.
Cancer of Bile Duct, Pancreatic Cancer
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in…
- Trial name
- NCT01041612
- Testing
- PTFE Covered ComVi [full covered] Biliary Stent
- Where
- 13 sites in Japan, South Korea
- Volunteers
- 120 people
- Sponsor
- Taewoong Medical Co., Ltd.
Cholecystitis, Acute
AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.
- Trial name
- NCT03767881
- Testing
- AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
- Where
- 7 sites in United States, Belgium
- Volunteers
- 30 people
- Sponsor
- Boston Scientific Corporation
Cholestatic Pruritus
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of twice-daily (BID) oral CR845 1.0 mg in patients with PBC with moderate-to-severe pruritus.
- Trial name
- NCT03995212
- Testing
- CR845 1.0 mg
- Where
- 14 sites in United States
- Volunteers
- 14 people
- Sponsor
- Cara Therapeutics, Inc.
Pulmonary Disease, Chronic Obstructive
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects
This study will investigate the safety and pharmacokinetics (PK) of a single dose of GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and age on drug exposure.
- Trial name
- NCT02006537
- Testing
- GSK2256294
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Sclerosing Cholangitis (PSC)
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT01672853
- Testing
- Simtuzumab
- Where
- 75 sites in United States, Belgium and 8 more
- Volunteers
- 235 people
- Sponsor
- Gilead Sciences
Advanced or Metastatic Solid Tumor
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab…
- Trial name
- NCT06270706
- Testing
- PLN-101095, Pembrolizumab
- Where
- 22 sites in United States, Spain
- Volunteers
- 124 people
- Sponsor
- Pliant Therapeutics, Inc.
Biliary Tract Cancer (BTC)
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
- Trial name
- TELE-ABC (NCT03790111)
- Testing
- telotristat ethyl
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- TerSera Therapeutics LLC
Biliary Tract Cancer
A Study to Evaluate the Association of Biliary Complications and Treatment Duration in Unresectable BTC Patients
This is a multi-center, retrospective, observational study of patients receiving first-line systemic therapy as routine clinical care for unresectable BTC in Japan.
- Trial name
- ARCBile (NCT07101874)
- Where
- 22 sites in Japan
- Volunteers
- 729 people
- Sponsor
- AstraZeneca
HER2-amplified Biliary Tract Cancers
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or…
- Trial name
- HERIZON-BTC-01 (NCT04466891)
- Testing
- ZW25 (Zanidatamab)
- Where
- 67 sites in United States, Canada and 7 more
- Volunteers
- 87 people
- Sponsor
- Jazz Pharmaceuticals
Biliary Tract Cancer
A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer
To evaluate the preliminary efficacy of KA2507 (an orally active potent and selective HDAC6 inhibitor) in patients with advanced biliary tract cancer (BTC) previously treated with standard of care chemotherapy.
- Trial name
- NCT04186156
- Testing
- KA2507
- Where
- United Kingdom
- Sponsor
- Karus Therapeutics Limited
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
Cholangiocarcinoma
A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas
This is a Phase I Dose Escalation Study in which the safety, tolerability and efficacy of Amphinex®--induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy will be assessed in…
- Trial name
- NCT01900158
- Testing
- Amphinex, Gemcitabine and Cisplatin
- Where
- 11 sites in France, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- PCI Biotech AS
Alagille Syndrome
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS).
- Trial name
- ASSERT-EXT (NCT05035030)
- Testing
- Odevixibat
- Where
- 35 sites in United States, Belgium and 8 more
- Volunteers
- 62 people
- Sponsor
- Albireo, an Ipsen Company