Clinical trials: sponsored by Eisai Inc.
Receptors, Estrogen, Genes, Erbb-2
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2…
- Conditions
- Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
- Trial name
- NCT04288089
- Testing
- Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Endometrial Neoplasms
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer.
- Trial name
- NCT03517449
- Testing
- Pembrolizumab, Lenvatinib, Paclitaxel
- Where
- 169 sites in United States, Argentina and 19 more
- Volunteers
- 827 people
- Sponsor
- Eisai Inc.
Alzheimer's Disease
A Study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects With Early Alzheimer's Disease
This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy…
- Trial name
- NCT01767311
- Testing
- Lecanemab 2.5 mg/kg, Lecanemab 5.0 mg/kg, Lecanemab 10 mg/kg
- Where
- 169 sites in United States, Canada and 9 more
- Volunteers
- 856 people
- Sponsor
- Eisai Inc.
Renal Cell Carcinoma
Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by…
- Trial name
- CLEAR (NCT02811861)
- Testing
- Lenvatinib, Everolimus, Pembrolizumab
- Where
- 183 sites in United States, Australia and 18 more
- Volunteers
- 1,069 people
- Sponsor
- Eisai Inc.
Melanoma, Carcinoma, Hepatocellular
A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors
The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2…
- Conditions
- Melanoma, Carcinoma, Hepatocellular, Colorectal Neoplasms
- Trial name
- NCT05091346
- Testing
- E7386, Pembrolizumab, Lenvatinib
- Where
- 32 sites in United States, Japan and 2 more
- Volunteers
- 89 people
- Sponsor
- Eisai Inc.
Epilepsies, Myoclonic
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.
- Trial name
- MOMENTUM 1 (NCT04572243)
- Testing
- Lorcaserin
- Where
- 30 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Eisai Inc.
Alzheimer Disease
A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease
The primary objective of the study is to assess the safety and tolerability of intravenous (IV) infusions of E2814 in participants with dominantly inherited Alzheimer's disease (DIAD), and to evaluate target engagement (TE) of…
- Trial name
- NCT04971733
- Testing
- E2814
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 8 people
- Sponsor
- Eisai Inc.
Renal Cell Carcinoma
Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide…
- Trial name
- NCT03173560
- Testing
- lenvatinib, everolimus
- Where
- 93 sites in United States, Australia and 14 more
- Volunteers
- 343 people
- Sponsor
- Eisai Inc.
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Solid Tumors
Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials
This study will be conducted to assess the long-term safety of study drug(s) in participants who are enrolled in Eisai-sponsored lenvatinib studies.
- Trial name
- NCT03477175
- Testing
- E7080, Comparator Drug, Comparator Drug: Sorafenib
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 40 people
- Sponsor
- Eisai Inc.
Persistent or Recurrent Cutaneous T-Cell Lymphoma
A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma
The purpose of this trial is to assess the efficacy of E7777 in participants with recurrent or persistent Cutaneous T-Cell Lymphoma (CTCL) in Stage I - III participants as assessed by objective response rate (ORR).
- Trial name
- NCT01871727
- Testing
- E7777 9 mcg/kg
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 112 people
- Sponsor
- Eisai Inc.
Insomnia
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2…
- Trial name
- SUNRISE 1 (NCT02783729)
- Testing
- Lemborexant, Zolpidem tartrate
- Where
- 102 sites in United States, Canada and 5 more
- Volunteers
- 1,006 people
- Sponsor
- Eisai Inc.
Solid Tumors
Study of Poly (ADP-Ribose) Polymerase (PARP) Inhibitor E7016 in Combination With Temozolomide in Subjects With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) of poly (ADP-Ribose) polymerase inhibitor E7016 when used with temozolomide (TMZ) in patients with advanced solid tumors and gliomas.
- Trial name
- NCT01127178
- Testing
- E7016 + TMZ
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Eisai Inc.
Osteosarcoma
A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma
This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents…
- Trial name
- NCT04154189
- Testing
- Lenvatinib, Ifosfamide, Etoposide
- Where
- 84 sites in United States, Australia and 19 more
- Volunteers
- 81 people
- Sponsor
- Eisai Inc.
Epilepsy
Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy
The purpose of this study is to evaluate the pharmacokinetics (PK) of perampanel during the Maintenance Period of the Core Study following oral suspension administration given as an adjunctive therapy in pediatric participants…
- Trial name
- NCT02914314
- Testing
- perampanel
- Where
- 18 sites in United States, Latvia
- Volunteers
- 26 people
- Sponsor
- Eisai Inc.
Lymphoma, Advanced Solid Tumors
Study of Intratumorally Administered Stimulator of Interferon Genes (STING) Agonist E7766 in Participants With Advanced Solid Tumors or Lymphomas - INSTAL-101
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants with advanced solid tumors or lymphomas.
- Trial name
- NCT04144140
- Testing
- E7766
- Where
- 13 sites in United States, France and 3 more
- Volunteers
- 24 people
- Sponsor
- Eisai Inc.
Colorectal Cancer
FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer
The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects.
- Trial name
- NCT01133990
- Testing
- FOLFIRI, E7820, Bevacizumab
- Where
- 34 sites in United States, Australia and 3 more
- Volunteers
- 5 people
- Sponsor
- Eisai Inc.
Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to [>=] 45 to less than [<] 65…
- Conditions
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiration Disorders
- Trial name
- NCT04647383
- Testing
- Lemborexant 10 mg
- Where
- 11 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Recurrent and Refractory Solid Tumors
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with…
- Trial name
- NCT03245151
- Testing
- Lenvatinib, Everolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Eisai Inc.
Tumors
A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors
This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with…
- Trial name
- NCT02501096
- Testing
- Lenvatinib, Pembrolizumab
- Where
- 64 sites in United States, Norway and 1 more
- Volunteers
- 357 people
- Sponsor
- Eisai Inc.