Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Advanced Solid Tumors
A Study of ASP1002 in Adults for Treatment of Solid Tumors
ASP1002 is being studied in people with tumors that have spread to nearby tissue (locally advanced) that cannot be removed by surgery (unresectable) or tumors that have spread to other parts of the body (metastatic).
- Trial name
- NCT05719558
- Testing
- ASP1002, Bevacizumab, Oxaliplatin
- Where
- 15 sites in United States
- Volunteers
- 798 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Urothelial Cancer and Other Malignant Solid Tumors
A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4
The purpose of this study is to evaluate the safety and pharmacokinetics of enfortumab vedotin as well as assess the immunogenicity and antitumor activity in subjects with metastatic urothelial cancer and other malignant solid…
- Trial name
- NCT02091999
- Testing
- enfortumab vedotin
- Where
- 21 sites in United States, Canada
- Volunteers
- 213 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) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
This was a clinical study for adult participants who were recently diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal.
- Trial name
- NCT02752035
- Testing
- gilteritinib, azacitidine
- Where
- 111 sites in United States, Australia and 11 more
- Volunteers
- 183 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hot Flashes
A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause.
- Trial name
- OPTION-VMS (NCT06049797)
- Testing
- Fezolinetant, Paroxetine, Citalopram
- Where
- 48 sites in United States
- Volunteers
- 999 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Urothelial Cancer
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer.
- Trial name
- EV-302 (NCT04223856)
- Testing
- Enfortumab vedotin, Pembrolizumab, Cisplatin
- Where
- 260 sites in United States, Argentina and 23 more
- Volunteers
- 886 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Geographic Atrophy, Age-Related Macular Degeneration
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 23 visit on study…
- Trial name
- NCT05536297
- Testing
- avacincaptad pegol
- Where
- 117 sites in United States, Argentina and 15 more
- Volunteers
- 278 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Stargardt's Macular Dystrophy
Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).
- Trial name
- NCT03364153
- Testing
- avacincaptad pegol
- Where
- 41 sites in United States, France and 6 more
- Volunteers
- 121 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the…
- Conditions
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms
- Trial name
- EV-103 (NCT03288545)
- Testing
- enfortumab vedotin (EV), pembrolizumab, cisplatin
- Where
- 106 sites in United States, Canada and 4 more
- Volunteers
- 348 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hot Flashes
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause
Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes.
- Trial name
- NCT06812754
- Testing
- Fezolinetant
- Where
- 26 sites in China
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer, Metastatic Castration Resistant Prostate Cancer
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle.
- Conditions
- Prostate Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Castration-sensitive Prostate Cancer
- Trial name
- NCT04729114
- Testing
- PRL-02 injection, prednisone, dexamethasone
- Where
- 25 sites in United States, Puerto Rico
- Volunteers
- 174 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Ureteral Cancer, Urothelial Cancer
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.
- Conditions
- Ureteral Cancer, Urothelial Cancer, Bladder Cancer
- Trial name
- NCT03474107
- Testing
- Enfortumab Vedotin, Docetaxel, Vinflunine
- Where
- 158 sites in United States, Argentina and 17 more
- Volunteers
- 608 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
A 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)
The purpose of the phase 1 portion (dose escalation) of the study was to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in…
- Trial name
- NCT04240002
- Testing
- gilteritinib, fludarabine, cytarabine
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Leukemia, Acute Myeloid (AML)
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line…
- Trial name
- NCT02421939
- Testing
- gilteritinib, LoDAC (Low Dose Cytarabine), Azacitidine
- Where
- 126 sites in United States, Belgium and 12 more
- Volunteers
- 371 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Kidney Transplantation
A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation.
- Trial name
- NCT01780844
- Testing
- ASKP1240, Tacrolimus, Mycophenolate Mofetil (MMF)
- Where
- 42 sites in United States
- Volunteers
- 149 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Psoriasis
A Multiple Dose Escalation Study of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to explore the safety and tolerability of multiple doses of ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects with moderate to severe psoriasis.
- Trial name
- NCT01585233
- Testing
- ASKP1240
- Where
- 13 sites in Australia, Canada and 1 more
- Volunteers
- 60 people
- Sponsor
- 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 in People With or Without Kidney Disease
The ureter is the tube that carries urine from the kidneys to the bladder. It is 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
- NCT05999747
- Testing
- pudexacianinium chloride
- Where
- 12 sites in United States
- Volunteers
- 95 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Fibromyalgia
A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia
The purpose of this study was to assess analgesic efficacy of ASP8062 relative to placebo as well as the safety and tolerability.
- Trial name
- NCT03092726
- Testing
- ASP8062
- Where
- 24 sites in United States
- Volunteers
- 183 people
- Sponsor
- Astellas Pharma Global Development, Inc.
B-cell Lymphoma
A Study to Find a Suitable Dose of ASP2802 in People With CD20-positive B-cell Lymphomas
CAR-T cell therapy is a type of treatment for people with certain lymphomas. T-cells are white blood cells that help to fight infections. CAR-T cell therapy improves the body's T-cells to help them better fight cancer cells.
- Trial name
- NCT06248086
- Testing
- ASP2802, MA-20
- Where
- Australia
- Volunteers
- 1 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Hormone Sensitive Prostate Cancer
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review.
- Trial name
- ARCHES (NCT02677896)
- Testing
- Enzalutamide
- Where
- 203 sites in United States, Argentina and 22 more
- Volunteers
- 1,150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors
A Study of ASP2074 in Adults With Solid Tumors
ASP2074 is a potential new treatment for people with certain solid tumors. Before ASP2074 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body.
- Trial name
- NCT05646797
- Testing
- ASP2074
- Where
- 13 sites in United States, Japan
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.