Clinical trials: sponsored by 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.
Lymphoma, T-cell, Peripheral, Lymphoma, T-cell, Cutaneous
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic…
- Trial name
- NCT05137847
- Testing
- Remitoro
- Where
- 3 sites in Japan
- Volunteers
- 118 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.
Solid Tumor or Lymphoma
An Open Label Dose Escalation Study Of E7080
The purpose of this study is to determine the maximum tolerated dose (MTD) of lenvatinib in patients with solid tumors or lymphomas.
- Trial name
- NCT00121719
- Testing
- Lenvatinib
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 82 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.
Non-small Cell Lung Cancer
Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer
This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.
- Trial name
- NCT01104155
- Testing
- eribulin mesylate + erlotinib
- Where
- 64 sites in United States, Hong Kong and 5 more
- Volunteers
- 123 people
- Sponsor
- Eisai Inc.
Soft Tissue Sarcoma
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study…
- Trial name
- NCT01327885
- Testing
- Eribulin mesylate 1.4 mg/m^2 intravenous, Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
- Where
- 119 sites in United States, Argentina and 21 more
- Volunteers
- 452 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.
Ovarian Cancer
E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125
The purpose of this study was to determine the maximum tolerated dose (MTD)/recommended Phase II dose of lenvatinib administered in combination with carboplatin and gemcitabine (Phase IB) and to evaluate the safety and…
- Trial name
- NCT01133756
- Testing
- Lenvatinib, Carboplatin, Gemcitabine
- Where
- United States
- Volunteers
- 7 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.
Refractory Solid Tumors, Lymphomas
A Double-Blind Study in Healthy Volunteers to Assess the Effect of E7080 on the QTc Interval
This is a double-blind (vis-a-vis lenvatinib), randomized, placebo-controlled, three-treatment, three-way crossover study in healthy subjects. There are two phases in this study: Pre-Randomization and Randomization.
- Trial name
- NCT01525394
- Testing
- Lenvatinib, Moxifloxacin 400 mg
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Colon Cancer, Rectal Cancer
Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal 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
- NCT01347645
- Testing
- FOLFIRI, E7820
- Where
- 38 sites in United States, Argentina and 4 more
- Volunteers
- 82 people
- Sponsor
- Eisai Inc.
Non-Small Cell Lung Cancer (NSCLC)
A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer
This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which…
- Trial name
- NCT01454934
- Testing
- Eribulin, TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
- Where
- 83 sites in United States, Australia and 12 more
- Volunteers
- 540 people
- Sponsor
- Eisai Inc.
Thyroid Cancer
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once…
- Trial name
- SELECT (NCT01321554)
- Testing
- Lenvatinib
- Where
- 155 sites in United States, Argentina and 21 more
- Volunteers
- 392 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.