Clinical trials: sponsored by Daiichi Sankyo
Diabetic Peripheral Neuropathic Pain
A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study)
This study will evaluate the safety and effectiveness of mirogabalin in adult patients with diabetic peripheral neuropathic pain (DPNP) in real-world clinical practice setting in China.
- Trial name
- NCT06812117
- Testing
- No Drug
- Where
- 43 sites in China
- Volunteers
- 721 people
- Sponsor
- Daiichi Sankyo
Peripheral T-cell Lymphomas, Adult T-cell Leukemia/Lymphoma
Medical Access Program for Valemetostat Tosylate (DS 3201b) For The Treatment of Patients With Relapsed/Refractory (R/R) Peripheral T-cell Lymphoma (PTCL)
Valemetostat tosylate demonstrates antitumour activity in patients with peripheral T-cell lymphomas (PTCL) with a manageable safety profile.
- Conditions
- Peripheral T-cell Lymphomas, Adult T-cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, Refractory Nodal T-follicular Helper Lymphoma
- Trial name
- NCT07862465
- Testing
- Valemetostat tosylate
- Sponsor
- Daiichi Sankyo
Unresectable Triple-negative Breast Cancer, Metastatic Triple-negative Breast Cancer
TROPION Breast Respond in 1L TNBC
There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
- Trial name
- NCT07867470
- Testing
- Dato-DXd
- Volunteers
- 400 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Advanced Testicular Germ Cell Tumors, Metastatic Testicular Germ Cell Tumors
Medical Access Program for DS-9606a (DS-9606) in Patients With Advanced Testicular Germ Cell Tumors
DS-9606a demonstrates antitumor activity in patients with solid tumors known to express CLDN-6, primarily in patients with testicular GCT, with a manageable safety profile with appropriate risk minimization measures.
- Trial name
- NCT07863284
- Testing
- DS-9606a
- Sponsor
- Daiichi Sankyo
Breast Cancer
DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and…
- Trial name
- NCT03529110
- Testing
- Trastuzumab deruxtecan (T-DXd), Ado-trastuzumab emtansine (T-DM1)
- Where
- 164 sites in United States, Australia and 13 more
- Volunteers
- 524 people
- Sponsor
- Daiichi Sankyo
Duchenne Muscular Dystrophy
Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
This is a multicenter, open-label, long-term, extension, phase 2 study to evaluate the safety and efficacy of long-term treatment with DS-5141b in patients with DMD who have completed DS5141-A-J101.
- Trial name
- NCT04433234
- Testing
- DS-5141b
- Where
- 2 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
WHO Grade II Glioma
A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
- Trial name
- NCT04458272
- Testing
- DS-1001b
- Where
- 11 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
SCLC, Extensive-stage Small Cell Lung Cancer
Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer
The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more…
- Trial name
- NCT07535359
- Testing
- Ifinatamab Deruxtecan
- Where
- 5 sites in United States
- Sponsor
- Daiichi Sankyo
Advanced Solid Tumor, Malignant Solid Tumor
Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts.
- Trial name
- NCT04145622
- Testing
- Ifinatamab deruxtecan (I-DXd)
- Where
- 23 sites in United States, Japan
- Volunteers
- 247 people
- Sponsor
- Daiichi Sankyo
Extensive Stage-small Cell Lung Cancer
A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)
This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small…
- Trial name
- NCT06362252
- Testing
- Ifinatamab deruxtecan, Atezolizumab, Carboplatin
- Where
- 58 sites in United States, France and 2 more
- Volunteers
- 123 people
- Sponsor
- Daiichi Sankyo
Hormone Receptor Positive, HER2-low or HER2-ultralow
A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer
The primary purpose of the study is to assess the safety, tolerability, and anti-tumor activity of HER3-DXd and T-DXd in the combination dosing regimens in participants with hormone receptor positive, HER2-low or HER2-ultralow…
- Conditions
- Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer
- Trial name
- NCT07701941
- Testing
- Patritumab deruxtecan, Trastuzumab deruxtecan
- Where
- 72 sites in United States, Belgium and 6 more
- Volunteers
- 220 people
- Sponsor
- Daiichi Sankyo
Hypercholesterolemia, Mixed Dyslipidemia
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
The primary objective is to describe in the real-world setting patient characteristics and outcomes of patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia using bempedoic…
- Trial name
- MILOS (NCT04579367)
- Testing
- Bempedoic acid and/or its fixed-dose combination with ezetimibe
- Where
- 443 sites in Austria, Belgium and 6 more
- Volunteers
- 5,000 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Primary Hypercholesterolemiia, Mixed Dyslipidemia
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.
- Trial name
- TRICONOS (NCT06686615)
- Testing
- Bempedoic acid, Ezetimibe, Rosuvastatin
- Where
- 163 sites in Austria, Belgium and 3 more
- Volunteers
- 2,000 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Coronary Atherosclerosis, Mixed Dyslipidemia
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and…
- Conditions
- Coronary Atherosclerosis, Mixed Dyslipidemia, Hypercholesterolemia
- Trial name
- NCT07474649
- Testing
- Bempedoic acid, Ezetimibe, Rosuvastatin
- Where
- 12 sites in Germany, Italy and 1 more
- Volunteers
- 103 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]
This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before.
- Trial name
- NCT03734029
- Testing
- Trastuzumab deruxtecan (DS-8201a), Capecitabine, Eribulin
- Where
- 208 sites in United States, Austria and 18 more
- Volunteers
- 557 people
- Sponsor
- Daiichi Sankyo
Metastatic Non Small Cell Lung Cancer
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer…
- Trial name
- TROPION-Lung08 (NCT05215340)
- Testing
- Datopotamab Deruxtecan, Pembrolizumab
- Where
- 234 sites in United States, Argentina and 26 more
- Volunteers
- 740 people
- Sponsor
- Daiichi Sankyo
Advanced Solid Tumor, Metastatic Solid Tumors
A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
This pan-tumor trial is designed as a signal-seeking trial to assess efficacy and safety of raludotatug deruxtecan (R-DXd) monotherapy in locally advanced or metastatic solid tumors with various cadherin-6 (CDH6) expression…
- Trial name
- NCT06660654
- Testing
- Raludotatug deruxtecan
- Where
- 48 sites in United States, Belgium and 7 more
- Volunteers
- 335 people
- Sponsor
- Daiichi Sankyo
Solid Tumors, Metastatic Solid Tumors
A Study of DS3610a in Participants With Advanced Solid Tumor
This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.
- Trial name
- NCT07159126
- Testing
- DS3610a
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 70 people
- Sponsor
- Daiichi Sankyo
Acute Myeloid Leukemia, Leukemia
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute…
- Trial name
- NCT06824168
- Testing
- Quizartinib High Dose, Quizartinib Low Dose
- Where
- 64 sites in United States, Australia and 3 more
- Volunteers
- 130 people
- Sponsor
- Daiichi Sankyo
Advanced Solid Tumor
A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
This study will evaluate the safety, tolerability, and efficacy of valemetostat tosylate in combination with DXd antibody-drug conjugates (ADC) in participants with advanced solid tumors.
- Trial name
- NCT06244485
- Testing
- Valemetostat tosylate, T-DXd, Dato-DXd
- Where
- 35 sites in United States, China and 2 more
- Volunteers
- 210 people
- Sponsor
- Daiichi Sankyo