A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

NCT04238481 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 5354-CL-0201
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery This study also investigated the safety, tolerability and the pharmacokinetics of ASP5354 in participants undergoing laparoscopic/minimally invasive colorectal surgery.

Conditions

Laparoscopic/Minimally Invasive Colorectal Surgery

Keywords

ASP5354; ureter visualization; imaging agent; near infrared fluorescence

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s)

  The anatomical visualization of the index ureter(s) was assessed by the investigator intraoperatively using a binary "Yes or No" question on the ability to visualize the ureter and was assessed as successful, if both 30 minutes after pudexacianinium chloride dosing and at end of surgery the visualization was assessed as positive (Yes)/successful. For imputation of missing values at 30 minutes after pudexacianinium chloride administration, the nearest time points before and after the 30 minutes was considered. If both time points (before and after 30 minutes) were successful, 30 minutes anatomical visualization was imputed as successful. If both time points were not successful, then 30 minutes anatomical visualization was imputed as not successful, and all other cases were not imputed.

  30 minutes postdose through end of surgery (on day 1)

Secondary Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events

  From first dose of study drug until follow-up period (day 10)

• Plasma Concentration of Pudexacianinium Chloride

  Predose, 10, 30, 60, 90, 120 minutes, end of surgery, 180 mins post dose

• Urine Concentration of Pudexacianinium Chloride

  Predose, 10, 30, 60, 90 minutes, end of surgery, 180 mins post dose

• Amount of Pudexacianinium Chloride Excreted in Urine (Ae) During Surgery

  During surgery (on day 1)

• Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%) During Surgery

  During surgery (on day 1)

Study Arms (4)

Pudexacianinium chloride - Dose Level A

EXPERIMENTAL

Participants received single dose of pudexacianinium chloride at dose level A by intravenous (IV) bolus infusion on day 1 once the surgical area of interest is in view.

Drug: Pudexacianinium chloride

Pudexacianinium chloride - Dose Level B

EXPERIMENTAL

Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.

Drug: Pudexacianinium chloride

Pudexacianinium chloride - Dose Level C

EXPERIMENTAL

Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.

Drug: Pudexacianinium chloride

Pudexacianinium chloride - Dose Level B - Dose Expansion

EXPERIMENTAL

Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.

Drug: Pudexacianinium chloride

Interventions

Pudexacianinium chloride DRUG

Intravenous

Also known as: ASP5354

Pudexacianinium chloride - Dose Level A; Pudexacianinium chloride - Dose Level B; Pudexacianinium chloride - Dose Level B - Dose Expansion; Pudexacianinium chloride - Dose Level C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is scheduled to undergo laparoscopic/minimally invasive colorectal surgery.
• Subject will need visualization of the ureter(s).
• Female subject is not pregnant and at least 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study treatment administration.
• Female subject must agree not to breastfeed starting at screening and throughout the study period.
• Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 30 days after final study treatment administration.
• Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after final study treatment administration.
• Male subject must not donate sperm during the treatment period and for 30 days after final study treatment administration.
• Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final study treatment administration.
• Subject agrees not to participate in another interventional study while participating in the present study.
• Subjects enrolled after optimal dose determination:
• Subject has any of the following values at screening:
• Body mass index \> 25
• Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m\^2 and \< 60. Subjects with an eGFR ≥ 60 mL/min/1.73 m\^2 may be considered after discussion with the medical monitor.

You may not qualify if:

• Subject is anticipated to require ureteral stenting during surgery.
• Subject has a history of known retroperitoneal fibrosis.
• Subject has an active urinary tract infection.
• Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Subject has any condition that makes the subject unsuitable for study participation.
• Subject has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
• Subject has had previous exposure to ASP5354.
• Subject has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III-IV) or other medical conditions that the investigator feels would impact safety or study compliance.
• Subject has a mean resting heart rate ≤ 45 bpm or ≥ 115 bpm, mean systolic blood pressure (SBP) ≥ 160 mmHg or mean diastolic blood pressure (DBP) ≥ 100 mmHg on day -1. If the mean blood pressure exceeds the limits above, repeat readings can be taken. Subject who has adequately controlled blood pressure is eligible.
• Subject has a mean corrected QT interval (Triplicate electrocardiogram \[ECG\]) using Fridericia's formula (QTcF) \> 430 msec (for male subjects) and \> 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, the mean of 1 additional triplicate ECG may be taken.
• Subject has any of the following screening laboratory values:
• Hemoglobin ≤ 9 g/dL
• Absolute neutrophil count ≤ 1500/µL
• Platelet count ≤ 100000/µL
• eGFR \< 60 mL/min/1.73 m\^2 (Not applicable to subjects enrolled after optimal dose determination.)

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Center for Colon and Rectal Surgery; AdventHealth Medical Group

Orlando, Florida, 32804, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Related Publications (1)

• Albert M, Delgado-Herrera L, Paruch J, Gerritsen-van Schieveen P, Kishimoto T, Takusagawa S, Cai N, Fengler J, Raizer J. Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery. Surg Endosc. 2023 Sep;37(9):7336-7347. doi: 10.1007/s00464-023-10193-9. Epub 2023 Jul 20.

  PMID: 37474823 DERIVED

Results Point of Contact

• Title: Clinical Trial Disclosure
• Organization: Astellas Pharma Inc

astellas.resultsdisclosure@astellas.com

+81 3-3244-6500 Japanese only

Study Officials

• Medical Monitor

  Astellas Pharma Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 23, 2020
• Study Start: October 6, 2020
• Primary Completion: November 18, 2021
• Study Completion: November 29, 2021
• Last Updated: October 24, 2024
• Results First Posted: February 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)