Clinical trials: Hepatic Malignancies
Hepatocellular Carcinoma, Liver Cancer
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation…
- Trial name
- CheckMate 9DX (NCT03383458)
- Testing
- Nivolumab
- Where
- 184 sites in United States, Argentina and 23 more
- Volunteers
- 545 people
- Sponsor
- Bristol-Myers Squibb
Melanoma (Skin), Metastatic Cancer
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells more sensitive to the drug.
- Trial name
- NCT00039234
- Testing
- aldesleukin, histamine dihydrochloride
- Where
- 19 sites in United States, Canada and 2 more
- Sponsor
- Maxim Pharmaceuticals
Leiomyoma
Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1002670 (Vilaprisan)
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
- Trial name
- NCT03092999
- Testing
- Vilaprisan (BAY1002670)
- Where
- 2 sites in Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatic Encephalopathy
A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]
This is a retrospective study in adult patients with cirrhosis and grade 3 or 4 HE (West Haven Criteria) to evaluate the effectiveness and safety of lactulose retention enema in the treatment of deep grade HE (West Haven…
- Trial name
- NCT02377947
- Where
- 3 sites in India
- Volunteers
- 50 people
- Sponsor
- Abbott
Neoplasms
A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants
This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer.
- Trial name
- NCT01767623
- Testing
- Vemurafenib
- Where
- 8 sites in United States, Australia and 5 more
- Volunteers
- 8 people
- Sponsor
- Hoffmann-La Roche
Pharmacokinetics, Healthy Subjects
A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects
The study aims to investigate and compare the effect of Mirabegron (YM178) on subjects with mild and moderate hepatic impairment compared to healthy subjects.
- Conditions
- Pharmacokinetics, Healthy Subjects, Mild and Moderate Hepatic Impairment
- Trial name
- NCT01579461
- Testing
- mirabegron
- Where
- Slovakia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
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 Solid Tumors
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.
- Trial name
- NCT02997176
- Testing
- Talazoparib
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Pfizer
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.
Colorectal Cancer, Liver Neoplasms
Safety & Efficacy of NV1020 in Colorectal Cancer Metastatic to the Liver
This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus…
- Trial name
- NCT00149396
- Testing
- NV1020
- Where
- 5 sites in United States
- Volunteers
- 32 people
- Sponsor
- MediGene
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function
The purpose of this study is to characterize the pharmacokinetics (what the body does to the study medication) of JNJ-38518168 at approximately steady-state (stable medication levels) after administration of multiple oral 30 mg…
- Trial name
- NCT01863784
- Testing
- JNJ-38518168
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
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
Multiple Myeloma
A Study of Belantamab Mafodotin in Multiple Myeloma Participants With Normal and Impaired Hepatic Function
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in Relapsed/Refractory Multiple Myeloma (RRMM) participants with impaired hepatic function and in…
- Trial name
- DREAMM 13 (NCT04398680)
- Testing
- Belantamab mafodotin
- Where
- 18 sites in United States, Greece and 1 more
- Sponsor
- GlaxoSmithKline
Hepatocellular Carcinoma
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
- Trial name
- EMERALD-2 (NCT03847428)
- Testing
- Durvalumab, Bevacizumab
- Where
- 217 sites in United States, Australia and 22 more
- Volunteers
- 908 people
- Sponsor
- AstraZeneca
Hepatic Impairment, Healthy Volunteers
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
- Trial name
- NCT06352528
- Testing
- Repotrectinib
- Where
- 3 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Multiple Myeloma
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form…
- Trial name
- NCT02921828
- Where
- 2 sites in United States, Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Solid Tumors
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
- Trial name
- NCT02063230
- Testing
- Selumetinib 50mg, Selumetinib 25mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma
Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors
This is an Open-label, Phase 1b/2 Study of the Pressure-Enabled Hepatic Artery Infusion (HAI) of SD-101, a TLR9 agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Hepatocellular Carcinoma (HCC)…
- Trial name
- NCT05220722
- Testing
- SD-101, Pembrolizumab, Nivolumab
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- TriSalus Life Sciences, Inc.
Hepatocellular Carcinoma
A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma
The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly advanced hepatocellular carcinoma for which…
- Trial name
- NCT00524498
- Testing
- OPC-18, cisplatin
- Where
- 7 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hepatic Carcinoma
Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.
- Trial name
- NCT01760616
- Testing
- Huaier Granule
- Where
- China
- Volunteers
- 790 people
- Sponsor
- Qidong Gaitianli Medicines Co., Ltd