Clinical trials: completed, sponsored by 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.
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.
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.
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.
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.
Breast Cancer
A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
The purpose of this study in patients with advanced breast cancer is to compare the incidence and severity of neuropathy adverse events for the two treatment groups (eribulin versus ixabepilone) using National Cancer Institute…
- Trial name
- NCT00879086
- Testing
- Eribulin Mesylate, Ixabepilone
- Where
- 50 sites in United States
- Volunteers
- 104 people
- Sponsor
- Eisai Inc.
Locally Recurrent, Metastatic Breast Cancer ( HER2 Negative)
A Study of Single-Agent Eribulin Mesylate as First-Line Therapy for Locally Recurrent or Metastatic Human Epidermal Growth Factor Receptor Two (HER2) Negative Breast Cancer
The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.
- Trial name
- NCT01268150
- Testing
- Eribulin mesylate
- Where
- 17 sites in United States
- Volunteers
- 56 people
- Sponsor
- Eisai Inc.
Breast Cancer
Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal…
- Trial name
- NCT01269346
- Testing
- Eribulin Mesylate
- Where
- 26 sites in United States
- Volunteers
- 52 people
- Sponsor
- Eisai Inc.
Advanced Solid Tumors
An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820 to Determine the Maximum Tolerated Dose Following Twice Daily Oral Administration in Subjects With Unresectable Solid Tumors
This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of Maximum Tolerated Dose [MTD] for twice daily [BID] Dosing).Part A will be initiated first, and Part B will be initiated after the PK…
- Trial name
- NCT01773421
- Testing
- E7820
- Where
- 6 sites in Netherlands, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Eisai Inc.
Non Small Cell Lung Cancer
Eribulin Mesylate Administered in Combination With Pemetrexed Versus Pemetrexed Alone as Second Line Therapy in Patients With Stage IIIB or IV Nonsquamous Non Small Cell Lung Cancer
The purpose of this study is to determine whether Eribulin Mesylate Administered in Combination with Pemetrexed is safe and tolerable and to gain a preliminary indication of clinical benefit when administered to Patients with…
- Trial name
- NCT01126736
- Testing
- eribulin mesylate, pemetrexed, Eribulin mesylate (eribulin; E7389)
- Where
- 18 sites in United States, Czechia and 3 more
- Volunteers
- 98 people
- Sponsor
- Eisai Inc.
Endometrial Cancer
Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression
To assess the objective response rate (ORR: complete response + partial response [CR+ PR]) of E7080 in subjects with unresectable endometrial cancer and disease progression following platinum-based, first-line chemotherapy. .
- Trial name
- NCT01111461
- Testing
- Lenvatinib
- Where
- 78 sites in United States, Belgium and 6 more
- Volunteers
- 133 people
- Sponsor
- Eisai Inc.