Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Melanoma

Breast Diseases

Skin Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

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

pudexacianinium chloride

Medical Monitor

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.

A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery

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

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.

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.

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.

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

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.

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.

Astellas Pharma Inc

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

ASP5354 0.2 mg

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

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

Clinical Trial Disclosure

Optimal Dose of ASP5354 for Lymph Node (LN) Visualization

Percentage of Participants With at Least 1 LN Detected Using ASP5354

Percentage of Identified LN Tissue by ASP5354 Compared With SOC Treatment

TEAE

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery	NCT05457842	Sentinel Lymph ... Breast Cancer Melanoma	pudexacianinium...	18 Years -	Astellas Pharma Inc
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery	NCT05457842	Sentinel Lymph ... Breast Cancer Melanoma	pudexacianinium...	18 Years -	Astellas Pharma Inc

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