Clinical trials: Hepatic Malignancies
BRAF V600 Mutation, Unresectable Melanoma
Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma
Encorafenib in combination with binimetinib have been approved in USA, Europe, Australia, Japan and Switzerland for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation.
- Conditions
- BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma, Hepatic Impairment
- Trial name
- NCT04759846
- Testing
- Encorafenib + Binimetinib
- Where
- 7 sites in Czechia, Italy and 1 more
- Sponsor
- Pierre Fabre Medicament
Moderate Hepatic Impairment
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
The purpose of this study is to measure the pharmacokinetics (PK), safety, and tolerability of capivasertib in participants with moderate hepatic impairment and participants with normal hepatic function (as control).
- Trial name
- NCT07343960
- Testing
- Capivasertib
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Hepatocellular Carcinoma, Liver Cancer
CS1008- in Combination With Sorafenib Compared to Sorafenib Alone in Subjects With Advanced Liver Cancer
The purpose of this study is to determine the safety and efficacy of CS-1008 in combination with sorafenib to sorafenib alone for treating liver cancer.
- Conditions
- Advanced Hepatocellular Carcinoma, Liver Cancer, Hepatic Cancer, Liver Neoplasms
- Trial name
- NCT01033240
- Testing
- CS-1008 2 mg/kg, Sorafenib, CS-1008 6/2 mg/kg
- Where
- 28 sites in United States, Japan and 2 more
- Volunteers
- 172 people
- Sponsor
- Daiichi Sankyo
Metastatic Pancreatic Carcinoma
Phase 1b Study of CAR2Anti-CEA CAR-T Cell Hepatic Infusions for Pancreatic Carcinoma Patients With CEA+ Liver Metastases
This study is an open-label, single arm phase 1b safety study of CAR2 Anti-CEA CAR-T cell hepatic arterial infusions for pancreatic carcinoma patients with carcinoembryonic antigen positive (CEA+) liver metastases resistant to…
- Trial name
- AntiCEA_CART (NCT03818165)
- Testing
- CAR2 Anti-CEA CAR-T cells
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Sorrento Therapeutics, Inc.
Hepatocellular Carcinoma
Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein
This is a two-arm, open-label, prospective, multi-center, randomized, active-controlled clinical trial to assess efficacy and safety of TheraSphere in comparison to standard of care therapy (sorafenib) in the treatment of…
- Trial name
- YES-P (NCT01887717)
- Testing
- TheraSphere®, Sorafenib
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 36 people
- Sponsor
- Boston Scientific Corporation
Non-small Cell Lung Cancer, Breast Cancer
A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer, Renal Cell Carcinoma
- Trial name
- NCT04440943
- Testing
- CDX-527
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celldex Therapeutics
Carcinoma, Hepatocellular, Biliary Tract Cancer
A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases
Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumors with predominant liver involvement.
- Conditions
- Carcinoma, Hepatocellular, Biliary Tract Cancer, Secondary Liver Cancer, Liver Metastases
- Trial name
- NCT04338685
- Testing
- RO7119929, Tocilizumab
- Where
- 10 sites in United States, Denmark and 4 more
- Volunteers
- 55 people
- Sponsor
- Hoffmann-La Roche
Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.
- Conditions
- Advanced Hepatocellular Carcinoma, Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms
- Trial name
- NCT02834780
- Testing
- H3B-6527
- Where
- 44 sites in United States, Belgium and 9 more
- Volunteers
- 128 people
- Sponsor
- H3 Biomedicine Inc.
Hepatic Insufficiency, Neoplasms
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies
The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.
- Trial name
- NCT05209295
- Testing
- Onureg
- Where
- 18 sites in United States, Argentina and 3 more
- Volunteers
- 2 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Insufficiency
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal…
- Trial name
- NCT01860326
- Testing
- Alisporivir
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Cancer, Cancer of Pancreas
Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors
This is a Phase 1b study to assess the safety and tolerability of STI-1386, an oncolytic virus, in subjects with relapsed and refractory solid tumors (RRSTs).
- Conditions
- Cancer, Cancer of Pancreas, Sarcoma, Hepatic Metastasis
- Trial name
- NCT05361954
- Testing
- STI-1386
- Volunteers
- 36 people
- Sponsor
- Sorrento Therapeutics, Inc.
Advanced or Metastatic Solid Tumor, Liver Failure
Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment
The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.
- Trial name
- NCT04617522
- Testing
- Sacituzumab Govitecan-hziy
- Where
- 15 sites in United States, France and 2 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Metastatic Uveal Melanoma in the Liver
Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma
This study is an open-label, phase 1/1b study of the pressure-enabled hepatic artery infusion of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in adults with metastatic uveal melanoma.
- Trial name
- NCT04935229
- Testing
- SD-101, Nivolumab, Ipilimumab
- Where
- 10 sites in United States
- Volunteers
- 67 people
- Sponsor
- TriSalus Life Sciences, Inc.
Cirrhosis, Liver, Hepatic Cirrhosis
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
This is a multi-center study to prospectively gather clinically-characterized plasma samples to determine the diagnostic performance characteristics (sensitivity and specificity) of the HCCBloodTest among patients with cirrhosis…
- Conditions
- Cirrhosis, Liver, Hepatic Cirrhosis, Hepatocellular Carcinoma, Liver Cancer
- Trial name
- NCT03804593
- Where
- 2 sites in United States
- Volunteers
- 175 people
- Sponsor
- Epigenomics, Inc
Liver Diseases, Digestive System Diseases
A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod
This is a Phase 1, multicenter, nonrandomized, open-label, parallel-group study in participants with mild or moderate hepatic impairment, and in participants with normal hepatic function.
- Trial name
- NCT04639115
- Testing
- Ozanimod
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Celgene
Liver Cancer
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic…
- Trial name
- NCT01286428
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Pathfinder Therapeutics
Solid Tumors, Hematologic Malignancies
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing.
- Conditions
- Solid Tumors, Hematologic Malignancies, Hepatic Impairment
- Trial name
- NCT01949545
- Testing
- Carfilzomib
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 46 people
- Sponsor
- Amgen
Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment
A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
- Trial name
- NCT01991678
- Testing
- 145 mg/m2 NKTR 102, 120 mg/m2 NKTR 102, 50 mg/m2 NKTR 102
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Nektar Therapeutics
Hepatic Impairment
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe…
- Trial name
- NCT05790304
- Testing
- Camizestrant
- Where
- 4 sites in United States, Bulgaria and 1 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.This study is seeking participants: - treated with the study medicine…
- Trial name
- NCT05912933
- Where
- United States
- Volunteers
- 1,342 people
- Sponsor
- Pfizer