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Astellas Pharma Global Development

66 clinical trials

3 abstracts

Clinical trial
A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Status: Completed, Estimated PCD: 2014-06-30
Clinical trial
A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Status: Completed, Estimated PCD: 2019-07-05
Clinical trial
A Phase 2 Study of Zolbetuximab (IMAB362) as Monotherapy and in Combination With Chemotherapy and/or Immunotherapy in Subjects With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and Locoregional Gastric or GEJ Adenocarcinoma Whose Are Claudin (CLDN) 18.2 Positive
Status: Recruiting, Estimated PCD: 2025-04-30
Clinical trial
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission
Status: Completed, Estimated PCD: 2021-05-25
Clinical trial
A Phase 3, Double-blind, Randomized, Multicenter, Parallel Group, Placebo-controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects From 5 to < 18 Years of Age With Overactive Bladder
Status: Terminated, Estimated PCD: 2023-07-07
Clinical trial
A Phase 1b Multiple Oral Dose Study to Evaluate the Pharmacological Effect, Safety and Tolerability of ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction
Status: Terminated, Estimated PCD: 2022-12-16
Clinical trial
A Phase 2, Open-Label, Non-Comparative, Multicenter Study to Evaluate the Safety and Tolerability, Efficacy and Pharmacokinetics of Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Subjects
Status: Completed, Estimated PCD: 2022-12-14
Clinical trial
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML
Status: Completed, Estimated PCD: 2023-03-01
Clinical trial
A Phase 2, Multicenter, Open-label Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Subjects With HER2+ AR+ Metastatic or Locally Advanced Breast Cancer
Status: Completed, Estimated PCD: 2017-02-28
Clinical trial
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP5354 in Participants With Renal Impairment Compared to Healthy Participants With Normal Renal Function
Status: Completed, Estimated PCD: 2023-04-27
Clinical trial
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Sequential, Multiple Dose Escalation Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis
Status: Completed, Estimated PCD: 2014-06-30
Clinical trial
A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4
Status: Completed, Estimated PCD: 2022-12-07
Clinical trial
A Phase 1/2, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of ASP0598 Otic Solution Following Topical Application Into the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)
Status: Terminated, Estimated PCD: 2023-01-24
Clinical trial
A Phase 3b, Randomized, Double-blind, Placebo-controlled, 24-week Study to Assess the Efficacy and Safety of Fezolinetant in Menopausal Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) and Considered Unsuitable for Hormone Replacement Therapy
Status: Completed, Estimated PCD: 2023-03-27
Clinical trial
A Phase 1 Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Renal Function
Status: Completed, Estimated PCD: 2022-03-06
Clinical trial
A Phase 1 Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Hepatic Function
Status: Completed, Estimated PCD: 2021-03-22
Clinical trial
A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Status: Active (not recruiting), Estimated PCD: 2024-09-30
Clinical trial
A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced/Metastatic Solid Tumors
Status: Active (not recruiting), Estimated PCD: 2024-04-30
Clinical trial
An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
Status: Recruiting, Estimated PCD: 2026-09-30
Clinical trial
A Phase 1/2, Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP7517 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express WT1 Antigen
Status: Active (not recruiting), Estimated PCD: 2024-06-30
Clinical trial
A Phase 1/1b Study of ASP2138 in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Status: Recruiting, Estimated PCD: 2026-06-30
Clinical trial
A First-in-Human, Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of a Single-Induction Dose of convertibleCARTM-T Cells Armed With MicAbodyTM Protein (ASP2802) Followed by Maintenance Booster Doses of the MicAbody Protein in Patients With CD20-Positive Relapsed or Refractory B-Cell Lymphomas
Status: Not yet recruiting, Estimated PCD: 2026-03-31
Clinical trial
A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Status: Active (not recruiting), Estimated PCD: 2018-10-14
Clinical trial
A Phase 1 Study of ASP1002 in Participants With Metastatic or Locally Advanced Solid Tumors
Status: Active (not recruiting), Estimated PCD: 2028-04-30
Clinical trial
A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Status: Completed, Estimated PCD: 2023-07-06
Clinical trial
A Phase 1, Open-Label, Dose Escalation and Expansion Study of ASP1012, an Oncolytic Virus, in Participants With Locally Advanced or Metastatic Solid Tumors
Status: Recruiting, Estimated PCD: 2029-04-30
Clinical trial
A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Status: Recruiting, Estimated PCD: 2027-12-31
Clinical trial
A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors
Status: Completed, Estimated PCD: 2023-03-27
Clinical trial
An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Status: Active (not recruiting), Estimated PCD: 2020-07-15
Clinical trial
A Global, Multicenter, Open-label, Early Access Program for Zolbetuximab (IMAB362) Plus mFOLFOX6 or CAPOX in Patients With Claudin18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Status:
Clinical trial
An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)
Status: Active (not recruiting), Estimated PCD: 2025-03-31
Clinical trial
A Phase 1/1b Study of ASP2074 in Participants With Metastatic or Locally Advanced Solid Tumors
Status: Active (not recruiting), Estimated PCD: 2027-09-30
Clinical trial
A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near-infrared Fluorescence (NIR-F) Imaging in Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
Status: Recruiting, Estimated PCD: 2024-07-31
Clinical trial
A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease
Status: Recruiting, Estimated PCD: 2025-11-30
Clinical trial
A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause
Status: Completed, Estimated PCD: 2020-10-29
Clinical trial
A Phase 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients With Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy
Status: Recruiting, Estimated PCD: 2028-07-31
Clinical trial
A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms
Status: Recruiting, Estimated PCD: 2025-09-30
Clinical trial
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Status: Recruiting, Estimated PCD: 2024-06-30
Clinical trial
A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed by a Non-Controlled Extension Treatment Period, to Assess the Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause
Status: Completed, Estimated PCD: 2020-07-30
Clinical trial
A Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging, Phase 2b Study to Investigate the Efficacy of ESN364 in Postmenopausal Women Suffering From Vasomotor Symptoms (Hot Flashes)
Status: Completed, Estimated PCD: 2018-09-19
Clinical trial
A Phase 1 Combined Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP8731 in Healthy Adult Participants, Including an Assessment of a Food Effect
Status: Terminated, Estimated PCD: 2022-11-10
Clinical trial
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma
Status: Completed, Estimated PCD: 2017-10-02
Clinical trial
A Phase 1b Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Status: Completed, Estimated PCD: 2022-05-10
Clinical trial
A Phase 1 Open Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP0367 in Participants With Renal Impairment Compared to Healthy Participants With Normal Renal Function
Status: Completed, Estimated PCD: 2022-11-13
Clinical trial
A Phase 1 Open-label Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP0367 Compared to Participants With Normal Hepatic Function
Status: Completed, Estimated PCD: 2022-01-11
Clinical trial
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
Status: Completed, Estimated PCD: 2021-10-11
Clinical trial
A Phase 1 Open-label Study to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics, Safety and Tolerability of Gilteritinib Compared to Healthy Participants With Normal Renal Function
Status: Completed, Estimated PCD: 2022-07-18
Clinical trial
A Phase 1, Open-label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]ASP0367 Solution in Healthy Male Participants
Status: Completed, Estimated PCD: 2022-04-30
Clinical trial
A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer
Status: Active (not recruiting), Estimated PCD: 2026-12-31
Clinical trial
A Phase 1/2 Open-label 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)
Status: Completed, Estimated PCD: 2023-04-21
Clinical trial
A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause
Status: Completed, Estimated PCD: 2022-01-04
Clinical trial
An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
Status: Recruiting, Estimated PCD: 2023-08-08
Clinical trial
A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express NY-ESO-1
Status: Completed, Estimated PCD: 2023-06-01
Clinical trial
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Status: Completed, Estimated PCD: 2017-09-28
Clinical trial
A Multicenter, Single-arm, Open-label, Postmarketing Safety Study to Evaluate the Risk of Seizure Among Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated With Enzalutamide Who Are at Potential Increased Risk of Seizure
Status: Completed, Estimated PCD: 2016-02-01
Clinical trial
A Phase 1 Multiple Ascending Intradermal Dose Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites
Status: Active (not recruiting), Estimated PCD: 2022-12-22
Clinical trial
A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Status: Recruiting, Estimated PCD: 2027-08-31
Clinical trial
A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy
Status: Not yet recruiting, Estimated PCD: 2026-10-31
Clinical trial
A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Status: Active (not recruiting), Estimated PCD: 2023-03-10
Clinical trial
A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula-Based Suspension in Children From 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
Status: Recruiting, Estimated PCD: 2026-06-30
Clinical trial
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Status: Active (not recruiting), Estimated PCD: 2022-09-09
Clinical trial
A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near Infrared Fluorescence (NIR-F) Imaging in Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
Status: Recruiting, Estimated PCD: 2024-08-31
Clinical trial
A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination With Chemotherapy (mFOLFIRINOX) in Participants With CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma
Status: Not yet recruiting, Estimated PCD: 2026-07-03
Clinical trial
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Status: Recruiting, Estimated PCD: 2026-07-31
Clinical trial
A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation
Status: Active (not recruiting), Estimated PCD: 2018-09-17
Clinical trial
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Status: Active (not recruiting), Estimated PCD: 2022-10-25
Abstract
Phase 2 trial of zolbetuximab in combination with mFOLFOX6 and nivolumab in patients with advanced or metastatic claudin 18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinomas.
Org: National Cancer Center Hospital East, Kashiwa, Japan, Society for Immunotherapy of Cancer, The Cancer Institute Hospital of JFCR, Tokyo, Japan, Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China, Astellas Pharma Global Development,
Abstract
Work absenteeism and disability days after diagnosis among patients with AML and caregivers.
Org: Duke Cancer Institute, Astellas Pharma Global Development, Real World Data Research & Analytics, Merative,
Abstract
Real-world baseline characteristics and first-line (1L) treatment (Tx) in patients (pts) with de novo metastatic castration-sensitive prostate cancer (mCSPC) by disease volume.
Org: Center for Integrated Research in Cancer and Lifestyle, Cedars-Sinai Medical Center, Formerly of Astellas Pharma Inc., Current affiliation, Pfizer Inc., Astellas Pharma Inc.,