Clinical trials: Advanced Malignancies and Hepatic Impairment
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
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 Cancer, Hepatic Impairment
Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours
To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.
- Trial name
- NCT00621725
- Testing
- AZD2171
- Where
- 3 sites in Denmark, Netherlands
- Volunteers
- 36 people
- Sponsor
- AstraZeneca
Advanced Malignancies and Hepatic Impairment
Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
The primary purpose of this study is to evaluate the impact of hepatic function on the pharmacokinetic (PK) profile of pelabresib in participants with advanced malignancies who have either hepatic impairment (HI) or normal liver…
- Trial name
- NCT07422610
- Testing
- pelabresib
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
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
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
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.
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
Hepatic Complications, Lymphoma
Temsirolimus in Treating Patients With Metastatic Solid Tumor or Lymphoma That Cannot Be Removed By Surgery Who Have Different Levels of Liver Function
This phase I trial is studying the side effects and best dose of temsirolimus in treating patients with metastatic solid tumor or lymphoma that cannot be removed by surgery who have different levels of liver function.
- Conditions
- Hepatic Complications, Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
- Trial name
- NCT00275093
- Testing
- temsirolimus, laboratory biomarker analysis, pharmacological study
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- National Cancer Institute (NCI)
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 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.
Neoplasms
Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor
Phase 1, open-label, parallel group, PK, safety and tolerability study in patients with an advanced solid tumor and either normal hepatic function (Group 1, n = 8) or moderate hepatic impairment (Group 2, n = 8) according to the…
- Trial name
- NCT03521037
- Testing
- Rucaparib camsylate
- Where
- 6 sites in Poland, Slovakia and 1 more
- Volunteers
- 16 people
- Sponsor
- pharmaand GmbH
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.
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.
Advanced Solid Tumor, Hepatic Impairment
Clinical Pharmacokinetic Study of Lurbinectedin in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment
Lurbinectedin is mainly eliminated by the liver. Thus, Hepatic Impairment (HI) may alter the plasma concentrations of lurbinectedin.
- Trial name
- NCT05101265
- Testing
- Lurbinectedin
- Where
- 6 sites in Spain
- Volunteers
- 24 people
- Sponsor
- PharmaMar
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
Advanced Cancer
Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients
This study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetics and safety of crizotinib in advanced cancer patients.
- Trial name
- NCT01576406
- Testing
- crizotinib
- Where
- 20 sites in United States
- Volunteers
- 88 people
- Sponsor
- Pfizer
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
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