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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

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)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

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

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

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

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of 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

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

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)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

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

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Have questions about or want more information about A Study of LY3471851 in Participants With Gastric Cancer? Contact us by filling out your information below and we’ll respond to you.

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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development.  Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared.  Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Participant received a single dose of 0.2 milligrams (mg) intradermal injection of ASP5354 on day 1.

This study was for women with breast cancer and for adults with melanoma.  Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control.  Melanoma was a type of skin cancer that starts in cells called melanocytes.  These cells made a substance called melanin which gives the skin its color.  In this study, people had surgery to remove the lymph node closest to the site of their cancer.  This lymph node was called the sentinel node.  This was done to check if the cancer had spread from the original site to the sentinel node. This procedure was called a sentinel node biopsy.

This study provided more information on a potential new dye, called ASP5354, used in sentinel node biopsies. ASP5354 helped to show the lymph nodes more clearly during surgery.  This helped the surgeon find the lymph node closest to the site of the cancer (sentinel node).

The main aim of the study was to find the best dose of ASP5354 that clearly showed the lymph nodes during surgery.  This was an open-label study.  That means each person in the study and the study doctors knew that person received ASP5354.

Each person only received 1 dose of ASP5354. 

People that wanted to take part in the study were checked by a study doctor. This was on a separate visit before their surgery.  Before surgery, people who took part in the study were asked if they had any other medical problems.  They had a physical exam, an ECG to check their heart rhythm, and had their vital signs checked (blood pressure, pulse rate, and breathing rate).  Other checks included some blood and urine samples taken for laboratory tests.  

During surgery, a study surgeon injected ASP5354 near the cancer site. They recorded how clearly they could see the lymph nodes. Some blood samples were taken for laboratory tests and an ECG was done.  After their surgery, people were asked if they have any other medical problems.

People returned to the hospital 9 days later for a check-up.  The check-up included a physical exam, an ECG to check their heart rhythm, and a check of their vital signs (blood pressure, pulse rate, and breathing rate).  Other checks included some blood samples taken for laboratory tests.  People were asked if they had any medical problems and asked to complete a feedback survey.

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

UCI Irvine Health-Chao Family Comprehensive Cancer Center Cancer

The University of Texas MD Anderson Cancer Center

A Phase 2 Open-label, Dose-finding Study to Determine the Optimal dose for Lymph Node Visualization using ASP5354 in Participants with Breast Cancer or Melanoma Undergoing Sentinel Lymph Node Biopsy

Optimal dose is defined as the dose that provides a better visualization compared to lower doses and a comparable visualization to the next higher dose.  In case where 2 doses performed equally, lower dose would be selected.  The optimal dose will be determined by the Visualization Review Committee (VRC) using data from the following assessments: LN tissue visualized (Y/N), visualized tissue is lymphatic in origin based on pathologic confirmation, Likert Scale determination of the intensity of fluorescence, and proportion of identified LN with histopathologic confirmation of LN tissue by ASP5354 compared with standard of care (SOC) treatment.

Age Categorical

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Full analysis set (FAS): Participant enrolled and received study Investigational product (IP).

The optimal dose was defined as the dose that provided a better visualization compared with lower doses and a comparable visualization to the next higher dose.  In the case where 2 doses performed equally, the lower dose was selected.  Cumulative visualization data of the LNs from all treated participants was used for optimal dose determination. The optimal dose was determined by the Visualization Review Committee (VRC) using data from the following assessments: LN tissue visualized (Y/N), visualized tissue is lymphatic in origin based on pathologic confirmation, Likert Scale determination of the intensity of fluorescence, and proportion of identified LN with histopathologic confirmation of LN tissue by ASP5354 compared with standard of care (SOC) treatment.

Optimal dose of ASP5354 for lymph node (LN) visualization

The visualization of at least 1 LN with histopathologic confirmation is assessed by using a binary "Yes" or "No" question. Those participants with "Yes" as response was reported.

Percentage of Participants with at least 1 LN detected using ASP5354

The percentage of identified LN with ASP5354 will be compared with SOC treatment with either Tc-99mSC or Lymphoseek, through histopathologic confirmation.

Percentage of identified LN tissue by ASP5354 compared with SOC treatment

TEAE

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered “serious” if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as an AE observed after starting administration of the study drug.

Safety Analysis Set (SAF): Participant enrolled and received study IP.

Number of Participants with Treatment Emergent Adverse Events (TEAE) and Serious adverse events (SAE)

Predose

10 minutes post dose

30 minutes post dose

60 minutes post dose

End of surgery post dose

Plasma concentration of ASP5354. The Lower limit of quantification (LLOQ) was defined as 1.00 nanograms per milliliter (ng/mL). Measured values below the LLOQ were expressed as <LLOQ and not reported.

Pharmacokinetic analysis set: All participants who received at least 1 dose of IP for which at least 1 plasma concentration data were available with the time of dosing and sampling.

Plasma concentration of ASP5354

Overall Study

Female participants ≥ 18 years of age diagnosed with localized breast cancer (stage 0 to 2,N0 and M0) or melanoma (stage 1 to 2, N0 and M0) scheduled to undergo surgical intervention for SLN detection and removal using technetium-99m sulfur colloid (Tc-99mSC) or Lymphoseek as part of standard of care (SOC).

Clinical Trial Disclosure

The visualization of at least 1 LN with histopathologic confirmation is assessed by using a binary "Yes" or "No" question.

The proportion of identified LN with ASP5354 will be compared with SOC treatment with either Technetium-99m sulfur colloid (Tc-99mSC) or Lymphoseek, through histopathologic confirmation.

Number of participants with potentially clinically significant vital sign values

Number of participants with potentially clinically significant ECG values

Number of participants with potentially clinically significant laboratory values.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study investigational product (IP), whether or not considered related to the study IP.  A TEAE is defined as an AE observed after administration of the IP and up to the follow up period.

Adverse event (AE) is considered “serious” if the event: results in death, is life-threatening, results in persistent or significant disability/incapacity, results in congenital anomaly or birth defect, requires hospitalization or prolongation to hospitalization, or other medically important event.

Concentration will be recorded from the PK plasma samples collected.