Clinical trials: Hepatic Malignancies
Advanced Cancers
Hepatic Impairment Study for Lorlatinib in Cancer Patients
This is a phase 1 study in advanced cancer patients with varied hepatic functions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients…
- Trial name
- NCT03726333
- Testing
- lorlatinib
- Where
- 10 sites in United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Lymphoma
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter…
- Trial name
- NCT03098589
- Testing
- Revlimid
- Where
- Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Neoplasm Malignant
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Primary Objectives: To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment To determine the pharmacokinetics (PKs) of…
- Trial name
- NCT01140607
- Testing
- Cabazitaxel (XRP6258)
- Where
- 14 sites in United States
- Volunteers
- 56 people
- Sponsor
- Sanofi
Breast Cancer, Leukemia, Myeloid, Chronic
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
The purpose of this study is to assess the pharmacokinetics of bosutinib and the safety and tolerability of bosutinib in healthy subjects and subjects with liver disease.
- Trial name
- NCT00759837
- Testing
- Bosutinib
- Where
- Poland
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hepatic Impairment, Healthy Participants
Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.
- Trial name
- NCT06425198
- Testing
- BMS-986278
- Where
- 4 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Hepatic Encephalopathy
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
- Trial name
- NCT00597909
- Testing
- sodium phenylacetate and sodium benzoate injection 10% / 10%
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Amgen
Locally Advanced Solid Tumor, Metastatic Solid Tumor
A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.
- Trial name
- NCT05828277
- Testing
- repotrectinib (TPX-0005)
- Where
- 2 sites in United States, Spain
- Sponsor
- Turning Point Therapeutics, Inc.
Neoplasms
Phase I Study of Anetumab Ravtansine in Hepatic or Renal Impairment
To characterize the safety, tolerability, pharmacokinetics and immunogenicity of anetumab ravtansine in subjects with advanced solid cancers and with different degrees of hepatic or renal impairment
- Trial name
- NCT02696642
- Testing
- Anetumab ravtansine (BAY94-9343)
- Where
- 8 sites in France, Moldova
- Volunteers
- 54 people
- Sponsor
- Bayer
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
Mild and Moderate Hepatic Impairment
Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function
- Trial name
- NCT04116476
- Testing
- MT-7117
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma America, Inc.
Metastatic Cancer
Pharmacokinetic and Safety Study of Pixantrone in Patients With Metastatic Cancer and Hepatic Impairment
This study will be conducted in patients with metastatic cancer and either moderate, severe, or no hepatic impairment who have failed other antineoplastic therapies or for whom there is no standard therapy.
- Trial name
- Hepatic (NCT01632436)
- Testing
- Pixantrone
- Where
- United States
- Sponsor
- CTI BioPharma
Cancer
A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors
This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of eFT508.
- Trial name
- NCT02605083
- Testing
- eFT508
- Where
- 4 sites in United States
- Volunteers
- 66 people
- Sponsor
- Effector Therapeutics
Oncology
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate)…
- Trial name
- NCT02521376
- Testing
- Entospletinib
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Ovarian Neoplasms, Neoplasms
Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment…
- Conditions
- Ovarian Neoplasms, Neoplasms, Solid Tumor, Hepatic Impairment
- Trial name
- NCT03359850
- Testing
- Niraparib
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Tesaro, Inc.
Hepatic Impairment
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389
The purpose of this study is to examine the safety and tolerability of AZD2389 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- CAMPOLINA (NCT06812780)
- Testing
- AZD2389
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Solid Tumors
A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function
This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer patients with adequate hepatic function versus cancer patients with moderate hepatic impairment.
- Trial name
- NCT00139620
- Testing
- Tarceva, erlotinib, OSI-774
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 39 people
- Sponsor
- OSI Pharmaceuticals
Hepatocellular Carcinoma
Hepatic Xenetix-CT Perfusion
The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in…
- Trial name
- NCT01639703
- Testing
- Xenetix-CT perfusion imaging
- Where
- 5 sites in Austria, Germany and 2 more
- Volunteers
- 96 people
- Sponsor
- Guerbet
Neoplasm Metastasis
Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden
The purpose of this study is to determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.
- Trial name
- OXi4503 (NCT00960557)
- Testing
- Combretastatin A1 Diphosphate (OXi4503)
- Where
- 4 sites in Australia
- Volunteers
- 16 people
- Sponsor
- Mateon Therapeutics
Solid Tumors, Hepatic Impairment
Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at single-dose and steady state in adult cancer patients either with mild, moderate or severe hepatic impairment or with normal hepatic function.
- Trial name
- NCT01443481
- Testing
- Dovitinib
- Where
- 12 sites in United States, Belgium and 4 more
- Volunteers
- 38 people
- Sponsor
- Novartis Pharmaceuticals
Colorectal Cancer, Gastric Cancer
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer.
- Conditions
- Colorectal Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer
- Trial name
- NCT02191761
- Testing
- SM04755
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Biosplice Therapeutics, Inc.