Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Intraoperative Ureter Visualization, Abdominolpelvic Surgery
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
The ureter was the tube that carries urine from the kidneys to the bladder. It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.
- Trial name
- NCT05754333
- Testing
- pudexacianinium chloride
- Where
- 6 sites in United States
- Volunteers
- 107 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma Cancer
Early Access Program for Zolbetuximab
This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or…
- Conditions
- Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma Cancer, Metastatic Gastric Adenocarcinoma Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- Trial name
- NCT06048081
- Testing
- zolbetuximab
- Where
- 140 sites in United States, Brazil and 4 more
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Malignancies, Advanced Cancer
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen
The purpose of this study was to evaluate the safety, tolerability, and clinical response of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of ASP7517 when administered as a…
- Trial name
- NCT04837196
- Testing
- ASP7517, Pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, CLDN18.2-positive Adenocarcinoma of Esophagus
Efficacy and Safety of IMAB362 in Combination With the EOX Regimen for CLDN18.2-positive Gastric Cancer
The purpose of the trial is to assess the therapeutic effects and the safety profile of IMAB362 combined with EOX (epirubicin, oxaliplatin, capecitabine) as first-line treatment for patients with advanced adenocarcinoma of the…
- Conditions
- CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, CLDN18.2-positive Adenocarcinoma of Esophagus, CLDN18.2-positive Gastric Adenocarcinoma
- Trial name
- FAST (NCT01630083)
- Testing
- epirubicin, oxaliplatin, capecitabine
- Where
- 48 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 252 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Arthritis, Rheumatoid
A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis
The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis (RA) subjects
- Trial name
- NCT01565655
- Testing
- peficitinib
- Where
- 38 sites in United States, Bulgaria and 4 more
- Volunteers
- 289 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer
Experiment to Assess Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Prostate Cancer Patients
The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the…
- Trial name
- NCT06500741
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 374 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors
A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or…
- Trial name
- NCT03260322
- Testing
- ASP8374, Pembrolizumab
- Where
- 54 sites in United States, Canada and 7 more
- Volunteers
- 169 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Cancer, Solid Tumors
A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors
The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D).
- Conditions
- Metastatic Cancer, Solid Tumors, Advanced Cancer
- Trial name
- NCT03954067
- Testing
- ASP9801, Pembrolizumab
- Where
- 17 sites in United States
- Volunteers
- 72 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction
A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction
The purpose of this study is to to evaluate the effect of ASP0367 on improvement of aerobic capacity relative to placebo, as well as evaluate the safety and tolerability of ASP0367 relative to placebo.
- Trial name
- NCT04855201
- Testing
- Bocidelpar
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Astellas Pharma Global Development, Inc.
HER2 Amplified, Advanced Breast Cancer
A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.
- Conditions
- HER2 Amplified, Advanced Breast Cancer, Human Epidermal Growth Factor Receptor 2 (HER2)
- Trial name
- NCT02091960
- Testing
- Enzalutamide, Trastuzumab
- Where
- 39 sites in United States, Belgium and 4 more
- Volunteers
- 103 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia
A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to…
- Trial name
- NCT02997202
- Testing
- gilteritinib
- Where
- 118 sites in United States, Australia and 14 more
- Volunteers
- 356 people
- Sponsor
- Astellas Pharma Global Development, Inc.
CLDN6-positive Solid Tumor, Ovarian Cancer
A Study of ASP1893 in Adults With Advanced CLDN6-positive Solid Tumors
Before a treatment can be approved for use, clinical studies need to be done. This study is for people with certain types of cancer that have become worse and are difficult to treat.
- Conditions
- CLDN6-positive Solid Tumor, Ovarian Cancer, Endometrial Cancer, Non-small Cell Lung Cancer
- Trial name
- NCT06681870
- Testing
- ASP1893
- Sponsor
- Astellas Pharma Global Development, Inc.
Kidney Transplantation
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants…
- Trial name
- ASTOUND (NCT02723591)
- Testing
- Tacrolimus, Tacrolimus immediate release
- Where
- 30 sites in United States
- Volunteers
- 599 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Ovarian Cancer, NSCLC
Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants
The purpose of this study was to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab.
- Conditions
- Ovarian Cancer, NSCLC, ESCC, Solid Tumors
- Trial name
- NCT04939701
- Testing
- ASP0739
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Castration-Resistant Prostate Cancer
A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients
The purpose of this study was to explore the safety and tolerability of enzalutamide in combination with abiraterone acetate plus prednisone.
- Trial name
- NCT01650194
- Testing
- enzalutamide, abiraterone acetate, prednisone
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Non-small Cell Lung Cancer (NSCLC)
A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or…
- Trial name
- SOLAR (NCT02588261)
- Testing
- naquotinib mesilate, Erlotinib, Gefitinib
- Where
- 167 sites in United States, Australia and 21 more
- Volunteers
- 530 people
- Sponsor
- 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.