Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide
The objective of this study was to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in participants with metastatic castration-resistant prostate cancer (mCRPC) known to have risk factor(s) for…
- Trial name
- UPWARD (NCT01977651)
- Testing
- Enzalutamide
- Where
- 76 sites in United States, Argentina and 18 more
- Volunteers
- 424 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Hepatocellular Carcinoma
A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
The purpose of the study was to evaluate the efficacy of enzalutamide in participants with advanced hepatocellular carcinoma (HCC) as measured by overall survival (OS).
- Trial name
- NCT02528643
- Testing
- Enzalutamide
- Where
- 38 sites in United States, Canada and 7 more
- Volunteers
- 165 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer
A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance
The primary purpose of this study was to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.
- Trial name
- ENACT (NCT02799745)
- Testing
- Enzalutamide, Active Surveillance
- Where
- 54 sites in United States, Canada
- Volunteers
- 227 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Invasive Mucormycosis, Invasive Aspergillosis
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
- Trial name
- NCT03816176
- Testing
- Isavuconazonium sulfate
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 31 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
The purpose of this study was to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus…
- Trial name
- NCT02921789
- Testing
- Bleselumab, Basiliximab, Mycophenolate Mofetil (MMF)
- Where
- 23 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia
Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML).
- Trial name
- NCT02014558
- Testing
- Gilteritinib, Voriconazole, Midazolam
- Where
- 26 sites in United States, Germany and 1 more
- Volunteers
- 265 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 (FLT3) mutated AML and…
- Trial name
- NCT03730012
- Testing
- gilteritinib, atezolizumab
- Where
- 12 sites in United States
- Volunteers
- 11 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Non-Small-Cell Lung Cancer
A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215.
- Trial name
- NCT02495233
- Testing
- Gilteritinib, Erlotinib
- Where
- 4 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1)…
- Trial name
- NCT02927262
- Testing
- Gilteritinib
- Where
- 73 sites in United States, Brazil and 19 more
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)
The purpose of this study was to evaluate the safety and tolerability and to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of ASP7517.
- Trial name
- NCT04079296
- Testing
- ASP7517
- Where
- 16 sites in United States, Japan
- Volunteers
- 43 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Menopause, Hot Flashes
A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)
This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes.
- Trial name
- NCT03192176
- Testing
- Fezolinetant
- Where
- 51 sites in United States
- Volunteers
- 356 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Chronic Tympanic Membrane Perforation
A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)
The primary purpose of this study was to evaluate the safety and tolerability of ASP0598 Otic Solution. This study also evaluated the efficacy of ASP0598 otic solution.
- Trial name
- NCT04305184
- Testing
- ASP0598
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Overactive Bladder (OAB)
Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
- Trial name
- PILLAR (NCT02216214)
- Testing
- Mirabegron
- Where
- 120 sites in United States, Canada
- Volunteers
- 888 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Use Disorder
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants
The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine.
- Trial name
- NCT04448561
- Testing
- ASP8082, morphine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Use Disorder
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062.
- Trial name
- NCT04447287
- Testing
- ASP8062, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors, Acute Myeloid Leukemia
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical…
- Trial name
- NCT02561455
- Testing
- Gilteritinib
- Where
- 7 sites in United States
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Renal Cell Carcinoma
A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
The purpose of this study was to evaluate the progression free survival (PFS), based on investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with metastatic renal cell carcinoma.
- Trial name
- NCT02639182
- Testing
- AGS-16C3F, Axitinib
- Where
- 26 sites in United States, Canada
- Volunteers
- 133 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Overactive Bladder (OAB), Pharmacokinetics of Mirabegron
A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
The purpose of this study was to evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB. This study will also evaluated the safety and tolerability of mirabegron in pediatric participants with OAB and…
- Trial name
- Dolphin (NCT04641975)
- Testing
- Mirabegron
- Where
- 15 sites in Belgium, France and 8 more
- Volunteers
- 26 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Chronic Obstructive Pulmonary Disease (COPD)
A Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease
The purpose of this study was to assess the effect of CK-2127107 relative to placebo on cycle ergometer exercise tolerance, assessed as change from period baseline in constant work rate (CWR) endurance time, utilizing a…
- Trial name
- NCT02662582
- Testing
- Reldesemtiv
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Incurable Platinum Refractory Germ Cell Tumors, Tumors
A Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors
The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650 (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed objective response rate (ORR) (phase 2) in…
- Trial name
- NCT03760081
- Testing
- ASP1650
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma Global Development, Inc.