Clinical trials: 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
Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and…
- Trial name
- NCT04619004
- Testing
- Patritumab Deruxtecan (Fixed dose), Patritumab Deruxtecan (Up-Titration)
- Where
- 123 sites in United States, Australia and 14 more
- Volunteers
- 277 people
- Sponsor
- Daiichi Sankyo
Non-small Cell Lung Cancer
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic…
- Trial name
- NCT04656652
- Testing
- DS-1062a, Docetaxel
- Where
- 209 sites in United States, Argentina and 24 more
- Volunteers
- 605 people
- Sponsor
- Daiichi Sankyo
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.
- Trial name
- NCT04703192
- Testing
- Valemetostat Tosylate
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 155 people
- Sponsor
- Daiichi Sankyo
Tenosynovial Giant Cell Tumor
A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT
This study will assess pexidartinib in adult participants with symptomatic TGCT that is associated with severe morbidity or functional limitations and not amendable to improvement with surgery.
- Trial name
- PLX3397 (NCT04488822)
- Testing
- Pexidartinib
- Where
- 9 sites in China, Taiwan
- Volunteers
- 40 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
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
Netherton Syndrome
A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome
Netherton Syndrome (NS) is a severe rare disease characterized by generalized scaling, erythema, and epidermal barrier defects. This study assessed the safety, pharmacokinetics (PK), and efficacy of DS-2325a in patients with NS.
- Trial name
- NCT05979831
- Testing
- DS-2325a
- Where
- France
- Volunteers
- 9 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
Breast Cancer
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug.
- Trial name
- NCT03248492
- Testing
- DS-8201a
- Where
- 99 sites in United States, Belgium and 7 more
- Volunteers
- 253 people
- Sponsor
- Daiichi Sankyo
Non-Small Cell Lung Cancer
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
- Trial name
- DESTINY-Lung01 (NCT03505710)
- Testing
- Trastuzumab deruxtecan
- Where
- 21 sites in United States, France and 3 more
- Volunteers
- 181 people
- Sponsor
- Daiichi Sankyo
Metastatic Colorectal Cancer
A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer
This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical…
- Trial name
- NCT04479436
- Testing
- Patritumab Deruxtecan
- Where
- 46 sites in United States, Belgium and 6 more
- Volunteers
- 40 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