Astellas Pharma Global Development, Inc. clinical trial failures

Review 29 stopped clinical trials from Astellas Pharma Global Development, Inc., including disease areas, phases, and classified stop reasons.

This page groups real ClinicalTrials.gov-derived stopped trial records. The strongest added signal is the stop-reason classification: 7 of these records are likely biological failure signals, while the rest may reflect operational, strategic, regulatory, funding, enrollment, or unclear stop reasons.

Total stopped trials29

Likely biological signals7

Shown below29

Dominant stop reasons

OPERATIONAL: 16
EFFICACY/FUTILITY: 6
OTHER/UNKNOWN: 6
SAFETY: 1

Notable sponsors

Astellas Pharma Global Development, Inc.: 29

Related phases

Phase I: 22
Phase II: 3
Phase III: 3
Phase IV: 1

Crawlable stopped-trial records

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Showing up to 29 representative records from this slice. Each link opens the trial detail page with source attribution and stop-reason context.

NCT05083481: A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors

Phase I Advanced Solid Tumors trial by Astellas Pharma Global Development, Inc.. Stop reason: OTHER/UNKNOWN.

Lack of clinical benefit

NCT06171178: A Study of ASP1012 in Adults With Solid Tumors

Phase I Solid Tumor trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Due to strategic decision made by the sponsor the study was terminated

NCT06544642: A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögren's Syndrome

Phase I Healthy Volunteers trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Company's strategic decision

NCT03288545: A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

Phase I Carcinoma, Transitional Cell trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Sponsor stopped the study after meeting enrollment targets and primary objectives, and after collecting sufficient data for planned regulatory filings. The decision was not due to safety concerns, futility, or any regulatory request.

NCT04240002: 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)

Phase I Acute Myeloid Leukemia (AML) trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

The study was terminated due to enrollment challenges.

NCT05014139: A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Phase I Urinary Bladder Neoplasms trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Trial was discontinued for strategic reasons. Decision was not based on safety concerns, futility, or request from regulatory authority, ethics committee, or institutional review board or EC/IRB.

NCT06248086: A Study to Find a Suitable Dose of ASP2802 in People With CD20-positive B-cell Lymphomas

Phase I B-cell Lymphoma trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

The termination of the study was a business decision made by the sponsor.

NCT05646797: A Study of ASP2074 in Adults With Solid Tumors

Phase I Advanced Solid Tumors trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Company Strategic Reasons

NCT04855201: A Study to Evaluate ASP0367 in Participants With Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction

Phase I Reduced Maximum Oxygen Uptake Due to Poor Systemic Oxygen Extraction trial by Astellas Pharma Global Development, Inc.. Stop reason: OTHER/UNKNOWN.

Lack of Pharmacological effect

NCT06681870: A Study of ASP1893 in Adults With Advanced CLDN6-positive Solid Tumors

Phase I CLDN6-positive Solid Tumor trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

A business decision was made to not initiate this study.

NCT04939701: Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants

Phase I Ovarian Cancer trial by Astellas Pharma Global Development, Inc.. Stop reason: OTHER/UNKNOWN.

The comprehensive assessment of other studies indicated the lack of significant monotherapy activity, therefore, team decided to terminate the study.

NCT02588261: 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

Phase III Non-small Cell Lung Cancer (NSCLC) trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies

NCT02495233: 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)

Phase I Non-Small-Cell Lung Cancer trial by Astellas Pharma Global Development, Inc.. Stop reason: SAFETY.

Study terminated due to adverse events related to the combination therapy

NCT04305184: A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects With Chronic Tympanic Membrane Perforation (CTMP)

Phase I Chronic Tympanic Membrane Perforation trial by Astellas Pharma Global Development, Inc.. Stop reason: EFFICACY/FUTILITY.

Lack of Efficacy

NCT03082300: A Study of ASP8273 in Subjects With Non-small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations

Phase I Non-small Cell Lung Cancer (NSCLC) trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.

NCT05167526: A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults

Phase I Healthy Participants trial by Astellas Pharma Global Development, Inc.. Stop reason: OTHER/UNKNOWN.

The study was terminated due to protocol defined stopping criteria being met.

NCT04641975: A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)

Phase III Overactive Bladder (OAB) trial by Astellas Pharma Global Development, Inc.. Stop reason: EFFICACY/FUTILITY.

Termination due to operational futility

NCT01705483: A Phase 1, Dose Escalation Study to Assess the Safety and Tolerability of ASP9853 With Either Docetaxel or Paclitaxel in Patients With Advanced Non-hematologic Malignancies

Phase I Pharmacokinetics of ASP9853 trial by Astellas Pharma Global Development, Inc.. Stop reason: OTHER/UNKNOWN.

Based on the results of the Phase 1 data, the company decided not to pursue the development of this drug at this time.

NCT05062577: A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder

Phase II Opioid Use Disorder trial by Astellas Pharma Global Development, Inc.. Stop reason: OTHER/UNKNOWN.

Due to corporate strategic considerations

NCT02610062: A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

Phase I Acute Myeloid Leukemia trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Business decision by sponsor

NCT03799003: A Study of ASP1951 in Subjects With Advanced Solid Tumors

Phase I Advanced Solid Tumors trial by Astellas Pharma Global Development, Inc.. Stop reason: EFFICACY/FUTILITY.

Study was terminated for lack of efficacy.

NCT03065959: A Study to Assess the Anti-fatigability Effect of CK-2127107 in Elderly Male and Female Subjects With Limitations in Mobility

Phase I Mobility Limitation trial by Astellas Pharma Global Development, Inc.. Stop reason: EFFICACY/FUTILITY.

Lack of efficacy determined at interim analysis

NCT02864290: A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

Phase I Acute Myeloid Leukemia trial by Astellas Pharma Global Development, Inc.. Stop reason: EFFICACY/FUTILITY.

Study was terminated due to lack of efficacy.

NCT04017208: A Study to Assess ASP2713 in Healthy Subjects

Phase I Healthy Volunteers trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

A business decision was made to not initiate this study.

NCT02372578: Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy

Phase II Painful Diabetic Peripheral Neuropathy (PDPN) trial by Astellas Pharma Global Development, Inc.. Stop reason: EFFICACY/FUTILITY.

The study was terminated due to futility analysis.

NCT02441517: A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment

Phase IV Metastatic Castration Resistant Prostate Cancer trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

The study is closed early due to lck of enrollment.

NCT02674555: A Study to Investigate the Absorption, Metabolism and Excretion of [14C]ASP8273 in Subjects With Solid Tumors

Phase I Epidermal Growth Factor Receptor (EGFR) Mutations trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.

NCT03042013: A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study

Phase II Subjects With NSCLC With an EGFR Activating Mutation trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

Following recommendation by SOLAR Study IDMC, Astellas closed enrollment in ASP8273 studies.

NCT00815516: Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis

Phase III Candidiasis trial by Astellas Pharma Global Development, Inc.. Stop reason: OPERATIONAL.

It was decided to discontinue the study due to insufficient recruitment.