Clinical trials: sponsored by Daiichi Sankyo
Acute Myeloid Leukemia
Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and…
- Trial name
- NCT02834390
- Testing
- Quizartinib, Cytarabine, Idarubicin
- Where
- Japan
- Volunteers
- 7 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
Breast Cancer, Urothelial Carcinoma
Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer
This is a study of trastuzumab deruxtecan for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens.
- Trial name
- NCT03523572
- Testing
- Trastuzumab deruxtecan, Nivolumab
- Where
- 29 sites in United States, Belgium and 5 more
- Volunteers
- 86 people
- Sponsor
- Daiichi Sankyo
Pseudoxanthoma Elasticum
A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum
This study was designed to evaluate the safety, tolerability, pharmacodynamics (PD) of DS-1211b, and pharmacokinetics (PK) in individuals with Pseudoxanthoma elasticum (PXE).
- Trial name
- NCT05569252
- Testing
- DS-1211b
- Where
- 7 sites in United States, Netherlands
- Volunteers
- 65 people
- Sponsor
- Daiichi Sankyo
Tenosynovial Giant Cell Tumor
Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy in previously treated participants with tenosynovial giant cell tumor (TGCT).
- Trial name
- PLX3397 (NCT04526704)
- Testing
- Pexidartinib
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 32 people
- Sponsor
- Daiichi Sankyo
Metastatic Breast Cancer
Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer.
- Trial name
- NCT02980341
- Testing
- Patritumab Deruxtecan
- Where
- 26 sites in United States, Japan
- Volunteers
- 182 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Central Neuropathic Pain
Study of Mirogabalin for Central Neuropathic Pain
Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo
- Trial name
- NCT03901352
- Testing
- Mirogabalin
- Where
- 118 sites in Japan, South Korea and 1 more
- Volunteers
- 300 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Acute Myeloid Leukemia, Leukemia
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer…
- Trial name
- QuANTUM-First (NCT02668653)
- Testing
- Chemotherapy, Quizartinib
- Where
- 244 sites in United States, Argentina and 26 more
- Volunteers
- 539 people
- Sponsor
- Daiichi Sankyo
Duchenne Muscular Dystrophy
Study of DS-5141b in Patients With Duchenne Muscular Dystrophy
This is a phase I/II study to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) profile of DS-5141b in patients with Duchenne muscular dystrophy (DMD) amenable to exon 45 skipping and to determine the dosage…
- Trial name
- NCT02667483
- Testing
- DS-5141b
- Where
- 2 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Dyslipidemia, Cardiovascular Diseases
Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete.
- Conditions
- Dyslipidemia, Cardiovascular Diseases, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Trial name
- SANTORINI (NCT04271280)
- Testing
- Non-interventional
- Where
- 540 sites in Austria, Belgium and 12 more
- Volunteers
- 9,559 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Gastrointestinal Stromal Tumors
DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)
This study will assess the safety, efficacy, and pharmacokinetics of DS-6157a in participants with advanced gastrointestinal stromal tumors (GIST).
- Trial name
- NCT04276415
- Testing
- DS-6157a
- Where
- 5 sites in United States, Japan
- Volunteers
- 34 people
- Sponsor
- Daiichi Sankyo
Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute
DS-3201b for Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)
This research study tests an investigational drug called DS-3201b. An investigational drug is a medication that is still being studied and has not yet been approved by the United States Food and Drug Administration (FDA).
- Trial name
- NCT03110354
- Testing
- DS-3201b
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Daiichi Sankyo
Advanced Solid Tumors
Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors
This is an open-label, two-part, multicenter study to evaluate the safety and tolerability of DS-8201a in participants with advanced solid malignant tumors.
- Trial name
- NCT02564900
- Testing
- DS-8201a (DP1), DS-8201a (DP2), DS-8201a (DP)
- Where
- 14 sites in United States, Japan
- Volunteers
- 292 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Neoplasm Metastasis
Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells.
- Trial name
- NCT03383692
- Testing
- DS-8201a, Ritonavir, Itraconazole
- Where
- 10 sites in Japan, South Korea and 1 more
- Volunteers
- 40 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Acute Myeloid Leukemia
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia.
- Trial name
- NCT03671564
- Testing
- Milademetan
- Where
- 8 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Giant Cell Tumors
Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project
TGCT is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. To date no disease registry exists and there is little data available detailing the management of patients with…
- Trial name
- TOP (NCT02948088)
- Where
- 15 sites in United States, Austria and 6 more
- Volunteers
- 183 people
- Sponsor
- Daiichi Sankyo
Deep Vein Thrombosis, Venous Thromboembolism
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug…
- Trial name
- NCT02303431
- Testing
- Edoxaban low dose, Edoxaban high dose
- Where
- 35 sites in United States, Canada and 7 more
- Volunteers
- 66 people
- Sponsor
- Daiichi Sankyo
Hepatic Impairment, Moderate Impaired Hepatic Function
A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment
Quizartinib is a novel oral Class III receptor tyrosine kinase (RTK) inhibitor exhibiting highly potent and selective but reversible inhibition of Feline McDonough sarcoma (FMS)-like tyrosine kinase 3 (FLT3).
- Trial name
- NCT04473664
- Testing
- Quizartinib
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Pulmonary Embolism, Thrombotic Disease
Study to Assess the Safety, Pharmacokinetics/Dynamics of DS-1040b in Subjects With Acute Submassive Pulmonary Embolism
This is a Phase 1b, double-blind (participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics (PK), and…
- Trial name
- NCT02923115
- Testing
- DS-1040b, Enoxaparin
- Where
- 46 sites in United States, Austria and 6 more
- Volunteers
- 134 people
- Sponsor
- Daiichi Sankyo
Non Small Cell Lung Cancer
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
This study has two parts: dose escalation and dose expansion. The primary objectives are: For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined with gefitinib in the study population and to…
- Trial name
- NCT03599518
- Testing
- DS-1205c, Gefitinib
- Where
- 8 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Daiichi Sankyo Co., Ltd.