Clinical trials: sponsored by Daiichi Sankyo
Healthy Subjects
A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects
Quizartinib, a selective FLT3 inhibitor, is being developed as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The absolute oral bioavailability of quizartinib has not yet been studied.
- Trial name
- NCT04796831
- Testing
- Quizartinib dihydrochloride, 14C-Quizartinib solution for infusion
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Adenocarcinoma, Gastric, Neoplasm, Breast
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
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
- NCT03368196
- Testing
- DS-8201a
- Where
- 2 sites in Taiwan
- Volunteers
- 12 people
- Sponsor
- Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
Cardiac Disease
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment.
- Trial name
- NCT03395639
- Testing
- Edoxaban, Standard of Care (SOC)
- Where
- 48 sites in United States, Austria and 12 more
- Volunteers
- 168 people
- Sponsor
- Daiichi Sankyo
Healthy Subjects, Drug-drug Interaction
A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants
This drug-drug interaction (DDI) study has been designed to investigate the effect of a moderate CYP3A inducer efavirenz on the pharmacokinetics of quizartinib and its major circulating active metabolite AC886.
- Conditions
- Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib
- Trial name
- NCT04459598
- Testing
- Efavirenz, Quizartinib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Acute Myeloid Leukemia
Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)
Participants with AML that have gone into remission and come back (relapsed) or gone into remission with a number of leukemia cells still in their system (refractory) will be recruited for this study.
- Trial name
- NCT03552029
- Testing
- Quizartinib, Milademetan
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Daiichi Sankyo
Pigmented Villonodular Synovitis, Giant Cell Tumors of the Tendon Sheath
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good.
- Conditions
- Pigmented Villonodular Synovitis, Giant Cell Tumors of the Tendon Sheath, Tenosynovial Giant Cell Tumor
- Trial name
- ENLIVEN (NCT02371369)
- Testing
- Pexidartinib
- Where
- 39 sites in United States, Australia and 10 more
- Volunteers
- 120 people
- Sponsor
- Daiichi Sankyo
Advanced Solid Tumors
Study of Pexidartinib in Asian Subjects With Advanced Solid Tumors
This is a Phase I, non-randomized, open-label, multiple dose study of pexidartinib in Asian subjects with advanced solid tumors.
- Trial name
- NCT02734433
- Testing
- Pexidartinib
- Where
- Taiwan
- Volunteers
- 12 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Malignant Neoplasm of Breast
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
This study will look at the effect on the QTc interval and pharmacokinetics after multiple dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
- Trial name
- NCT03366428
- Testing
- DS-8201a
- Where
- 7 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Atrial Fibrillation
Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.
- Trial name
- NCT02943785
- Testing
- Edoxaban-based Regimen, VKA-based Regimen
- Where
- 230 sites in United States, Austria and 12 more
- Volunteers
- 1,426 people
- Sponsor
- Daiichi Sankyo
Neoplasm, Gastrointestinal
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed…
- Trial name
- NCT03329690
- Testing
- DS-8201a, Physician's Choice
- Where
- 66 sites in Japan, South Korea
- Volunteers
- 233 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Non-small Cell Lung Cancer (NSCLC)
DS-1205c With Osimertinib 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 osimertinib in the study population and to…
- Trial name
- NCT03255083
- Testing
- DS-1205c, Osimertinib
- Where
- 7 sites in Taiwan
- Volunteers
- 13 people
- Sponsor
- Daiichi Sankyo
Solid Tumor
Safety Study of PLX108-01 in Patients With Solid Tumors
PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable…
- Trial name
- NCT01004861
- Testing
- PLX3397
- Where
- 13 sites in United States
- Volunteers
- 132 people
- Sponsor
- Daiichi Sankyo
Acute Coronary Syndrome (ACS)
Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)
This Phase IV, multicenter trial is designed to assess the efficacy of prasugrel in preventing the formation of blood clots in Taiwanese patients with ACS who have been treated with PCI.
- Trial name
- NCT03672097
- Testing
- Prasugrel
- Where
- 10 sites in Taiwan
- Volunteers
- 204 people
- Sponsor
- Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
Colorectal Neoplasm
DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.
- Trial name
- NCT03384940
- Testing
- DS-8201a
- Where
- 25 sites in United States, Italy and 3 more
- Volunteers
- 86 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
This study will take place in parts: Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules Dose Escalation (Part 1A): Participants receive milademetan in combination with 5-azacytidine…
- Trial name
- NCT02319369
- Testing
- Milademetan, AZA
- Where
- 5 sites in United States
- Volunteers
- 74 people
- Sponsor
- Daiichi Sankyo
Solid Tumors, Non-small Cell Lung Carcinoma
A Study of DS-2248 in Participants With Advanced Solid Tumors
This phase 1 clinical trial is intended to understand the safety and tolerability of a new anticancer drug in subjects with advanced solid tumors.
- Trial name
- NCT01288430
- Testing
- DS-2248
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Daiichi Sankyo
Type 2 Diabetes Mellitus
Study of Rivoglitazone in Type 2 Diabetes Mellitus
This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy.
- Trial name
- NCT00484198
- Testing
- Pioglitazone, Rivoglitazone
- Where
- 183 sites in United States, Argentina and 16 more
- Volunteers
- 1,912 people
- Sponsor
- Daiichi Sankyo
Healthy Subjects, Drug-drug Interaction
A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants
The purpose of this study is to investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants.
- Conditions
- Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib
- Trial name
- NCT04459585
- Testing
- Dabigatran Etexilate Mesylate, Quizartinib
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Coronary Artery Disease
Prasugrel/Clopidogrel Maintenance Dose Washout Study
The primary objective of the study is to describe the cumulative proportion of participants who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenance dose) following discontinuation of…
- Trial name
- NCT01014624
- Testing
- Prasugrel, Clopidogrel
- Where
- 4 sites in United States
- Volunteers
- 56 people
- Sponsor
- Daiichi Sankyo
Moderate Hepatic Impairment
Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants
The pharmacokinetics of a single dose of pexidartinib was investigated in participants with impaired hepatic function and compared with healthy control participants with normal hepatic function.
- Trial name
- NCT04223635
- Testing
- Pexidartinib
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo