Clinical trials: Advanced Malignancies and Hepatic Impairment
- Condition Advanced Malignancies and Hepatic Impairment
- Funder type Industry (pharma, biotech, devices)
Advanced Solid Tumors, Hematologic Malignancies
Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing…
- Trial name
- SPI-FOL-102 (NCT07036133)
- Testing
- Pralatrexate Injection
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Acrotech Biopharma Inc.
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
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.
Hepatic Impairment, Advanced Malignant Solid Tumor
A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function
This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe…
- Trial name
- NCT04241835
- Testing
- Tazemetostat
- Where
- 14 sites in United States, Belgium and 3 more
- Volunteers
- 18 people
- Sponsor
- Epizyme, 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
Histologically-proven and Radiologically-confirmed Solid Tumors
An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function
This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment.
- Trial name
- NCT01278849
- Testing
- ASA404
- Where
- 4 sites in Italy, New Zealand
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Esophageal Cancer, Advanced Solid Tumor
Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function
To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT05048368
- Testing
- Larotinib
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Advanced High-Grade Epithelial Ovarian Cancer, Primary Peritoneal Cancer
A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with…
- Conditions
- Advanced High-Grade Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancers
- Trial name
- NCT06682988
- Testing
- Mirvetuximab Soravtansine
- Where
- 52 sites in United States, Australia and 6 more
- Volunteers
- 110 people
- Sponsor
- AbbVie
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
Solid Tumours
Study to Assess the Blood Levels and Safety of AZD9291 in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function…
- Trial name
- NCT02161770
- Testing
- AZD9291 tablet dosing, Pharmacokinetic sampling - AZD9291, Pharmacokinetic sampling - AZ5140 and AZ7550
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Advanced Non-small Cell Lung Cancer
Pharmacokinetic Study of HS-10241 Tablets in Subjects with Hepatic Impairment and Normal Hepatic Function
This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages.
- Trial name
- NCT06823245
- Testing
- HS-10241
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Advanced Malignancies
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment.
- Trial name
- NCT04831944
- Testing
- parsaclisib
- Where
- 5 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
NSCLC (advanced Non-small Cell Lung Cancer)
Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic Function
This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages.
- Trial name
- NCT06823258
- Testing
- HS-10365
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
Cancer, Advanced Hepatocellular Carcinoma
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients
The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or moderate liver disease by providing information on any potential side effects this drug may cause and collecting data about how…
- Trial name
- NCT00999882
- Testing
- AZD8055
- Where
- 3 sites in Hong Kong, South Korea
- Volunteers
- 26 people
- Sponsor
- AstraZeneca
Carcinoma, Hepatocellular
A Study of Brivanib (BMS-582664) in Patients With Liver Cancer and Mild, Moderate or Severe Liver Dysfunction
The primary purpose of this protocol is to determine the effect of BMS-582664 on patients with hepatocellular carcinoma with varying levels of hepatic impairment
- Trial name
- NCT00437424
- Testing
- Brivanib
- Where
- 5 sites in United States, Spain
- Volunteers
- 24 people
- Sponsor
- Bristol-Myers Squibb
Advanced Solid Tumors
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.
- Trial name
- NCT02301104
- Testing
- TAS-102
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Taiho Oncology, Inc.
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