Clinical trials: Biliary Tract Diseases
Primary Sclerosing Cholangitis
A Study of NGM282 in Patients With Primary Sclerosing Cholangitis
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.
- Trial name
- NCT02704364
- Testing
- NGM282
- Where
- 38 sites in United States, France and 2 more
- Volunteers
- 62 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Advanced Solid Tumors, Biliary Tract Cancer
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid…
- Trial name
- NCT03440450
- Testing
- FF-10832 Gemcitabine Liposome Injection
- Where
- 7 sites in United States
- Volunteers
- 90 people
- Sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
Primary Biliary Cholangitis
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
- Trial name
- NCT06247735
- Testing
- K-808 (Dose A), K-808 (Dose B)
- Where
- 38 sites in United States, Canada and 1 more
- Volunteers
- 46 people
- Sponsor
- Kowa Research Institute, Inc.
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC).
- Trial name
- NCT01949870
- Testing
- Cisplatin, Gemcitabine, Selumetinib
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Obesity
Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones
The study is designed to assess whether repeated dosing with CE-326,597 will cause patients with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become symptomatic.
- Trial name
- NCT00576589
- Testing
- CE-326,597
- Where
- 12 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infantile Refsum's Disease, Zellweger Syndrome
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II.
- Conditions
- Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders
- Trial name
- NCT00007020
- Testing
- Cholic Acids
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholangiocarcinoma
PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer
This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in…
- Trial name
- RELEASE (NCT04099888)
- Testing
- Fimaporfin and Gemcitabine, Gemcitabine/Cisplatin chemotherapy
- Where
- 50 sites in United States, Belgium and 12 more
- Volunteers
- 41 people
- Sponsor
- PCI Biotech AS
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
Breast Cancer, Head and Neck Cancer
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
This study evaluated the intratumoral administration of escalating doses of a novel, experimental drug, INT230-6. The study was conducted in patients with several types of refractory cancers including those at the surface of the…
- Conditions
- Breast Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, Lymphoma
- Trial name
- IT-01 (NCT03058289)
- Testing
- INT230-6, anti-PD-1 antibody, anti-CTLA-4 antibody
- Where
- 8 sites in United States, Canada
- Volunteers
- 111 people
- Sponsor
- Intensity Therapeutics, Inc.
Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
Validation of the Itch Reported Outcome (ItchRO) Diaries in Pediatric Cholestatic Liver Disease
The purpose of the study is to validate the ItchRO instrument (a clinical outcome assessment measure of itching) prior to the analysis of longitudinal treatment effect data being generated in ongoing clinical trials.
- Trial name
- NCT02131623
- Where
- 5 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Selected Advanced Solid Tumors, Colorectal Cancer (CRC)
SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors
This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors.
- Conditions
- Selected Advanced Solid Tumors, Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Biliary Tract Cancer (BTC)
- Trial name
- NCT07812805
- Testing
- SKL35501, SKL35502
- Where
- 5 sites in United States, South Korea
- Volunteers
- 100 people
- Sponsor
- SK Life Science, Inc.
Advanced or Metastatic Solid Tumor, Pancreatic Ductal Adenocarcinoma
AB122 Platform Study
This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.
- Conditions
- Advanced or Metastatic Solid Tumor, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT04999761
- Testing
- AB122, TAS-116, TAS-120
- Where
- 9 sites in Japan
- Volunteers
- 917 people
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
Primary Biliary Cholangitis
Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis
Saroglitazar Magnesium 1 mg and 2 mg tablets for treatment of subjects with Primary Biliary Cholangitis (PBC)
- Trial name
- EPICS-III (NCT05133336)
- Testing
- Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
- Where
- 57 sites in United States, Argentina and 2 more
- Volunteers
- 196 people
- Sponsor
- Zydus Therapeutics Inc.
Primary Sclerosing Cholangitis
Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis
Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.
- Trial name
- NUC-3 (NCT01755507)
- Testing
- norUDCA
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 159 people
- Sponsor
- Dr. Falk Pharma GmbH
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic…
- Trial name
- FIDES-01 (NCT03230318)
- Testing
- derazantinib
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 148 people
- Sponsor
- Basilea Pharmaceutica
Biliary Tract Cancer
A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 compared with the investigator's choice of protocol in patients with locally advanced or…
- Trial name
- NCT07582315
- Testing
- BL-B01D1, Oxaliplatin, Calcium levofolinate
- Where
- China
- Volunteers
- 538 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Cholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease
- Trial name
- NCT06825559
- Testing
- Saroglitazar Magnesium 1 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zydus Therapeutics Inc.
HER2 Mutation-Related Tumors, HER2 Amplified Solid Tumors
ARX788 in Selected HER2-mutated or HER2-amplified/Overexpressed Solid Tumors (ACE-Pan Tumor-02)
A Global Phase 2 Study to Evaluate the Efficacy and Safety of ARX788 for Selected HER2-mutated or HER2-amplified/overexpressed Solid Tumors (ACE-Pan tumor-02)
- Trial name
- NCT05041972
- Testing
- ARX788
- Where
- 2 sites in United States
- Sponsor
- Ambrx, Inc.
Cancer, Solid Tumor
Study to Evaluate the Safety and Tolerability of RXC004 in Advanced Malignancies
The purpose of this study is to determine the safety and tolerability of RXC004 as monotherapy and in combination with Nivolumab in patients with advanced malignancies.
- Trial name
- NCT03447470
- Testing
- RXC004, Nivolumab
- Where
- 5 sites in United Kingdom
- Volunteers
- 46 people
- Sponsor
- Redx Pharma Ltd