Clinical trials: completed, sponsored by 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
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
Tenosynovial Giant Cell Tumor
A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan
This phase 2, multicenter, two-part, open-label, single-arm study will be conducted in Japan and will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of pexidartinib in adult participants with symptomatic…
- Trial name
- NCT04703322
- Testing
- Pexidartinib
- Where
- 6 sites in Japan
- Volunteers
- 9 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Systemic Lupus Erythematosus
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by autoantibody production, inflammation, and tissue damage in multiple organs.
- Trial name
- NCT05638802
- Testing
- DS-7011a
- Where
- 20 sites in United States, China and 2 more
- Volunteers
- 26 people
- Sponsor
- Daiichi Sankyo
Non-small Cell Lung Cancer
Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.
- Trial name
- NCT04484142
- Testing
- DS-1062a
- Where
- 84 sites in United States, France and 8 more
- Volunteers
- 137 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: cannot be removed by an operation has spread to other parts of the body
- Trial name
- NCT03523585
- Testing
- Trastuzumab deruxtecan, Capecitabine, Lapatinib
- Where
- 227 sites in United States, Australia and 13 more
- Volunteers
- 608 people
- Sponsor
- Daiichi Sankyo
Advanced Colorectal Cancer
Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic…
- Trial name
- DESTINY-CRC02 (NCT04744831)
- Testing
- DS-8201a 5.4 mg/kg Q3W, DS-8201a 6.4 mg/kg Q3W
- Where
- 63 sites in United States, Australia and 8 more
- Volunteers
- 122 people
- Sponsor
- Daiichi Sankyo
Melanoma
A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma
The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.
- Trial name
- NCT02975700
- Testing
- PLX3397
- Where
- 5 sites in China, South Korea
- Volunteers
- 6 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Non-Small Cell Lung Cancer
Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one…
- Trial name
- DESTINY-LUNG02 (NCT04644237)
- Testing
- Trastuzumab deruxtecan
- Where
- 50 sites in United States, Australia and 8 more
- Volunteers
- 152 people
- Sponsor
- Daiichi Sankyo
Adenocarcinoma Gastric Stage IV With Metastases, Adenocarcinoma - GEJ
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.
- Trial name
- NCT04014075
- Testing
- Trastuzumab deruxtecan
- Where
- 37 sites in United States, Belgium and 3 more
- Volunteers
- 79 people
- Sponsor
- Daiichi Sankyo
Venous Thromboembolism
Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Europe
According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and…
- Trial name
- ETNA-VTE (NCT02943993)
- Testing
- Edoxaban
- Where
- Germany
- Volunteers
- 2,809 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Advanced Solid Tumor, Lymphoma
A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas
This will be a Phase 1, open-label study of milademetan to assess its safety and tolerability, identify a maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and assess its pharmacokinetic (PK)/…
- Trial name
- NCT01877382
- Testing
- Milademetan
- Where
- 5 sites in United States
- Volunteers
- 107 people
- Sponsor
- 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