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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04238481
Recruitment Status : Completed
First Posted : January 23, 2020
Results First Posted : February 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Tracking Information
First Submitted Date  ICMJE January 20, 2020
First Posted Date  ICMJE January 23, 2020
Results First Submitted Date  ICMJE January 18, 2023
Results First Posted Date  ICMJE February 13, 2023
Last Update Posted Date September 13, 2023
Actual Study Start Date  ICMJE October 6, 2020
Actual Primary Completion Date November 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2023)
Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s) [ Time Frame: 30 minutes postdose through end of surgery (on day 1) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
Success rate of anatomical visualization of the index ureter(s) [ Time Frame: Up to end of surgery (Day 1) ]
The incidence of anatomical visualization of ureter(s) will be assessed by the investigator intraoperatively using a binary "Yes or No" question on the ability to visualize the ureter: "Can the ureter be adequately visualized with near-infrared fluorescence (NIR-F)"? If the answer to the question 30 minutes after ASP5354 administration and at the end of surgery = Yes, then anatomical visualization of the index ureter(s) of a participant is considered as a success.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2023)
  • Number of Participants With Treatment Emergent Adverse Events [ Time Frame: From first dose of study drug until follow-up period (day 10) ]
    An adverse event (AE) was any untoward medical occurrence in a participant administered an investigational product (IP), and which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP. A TEAE was defined as an AE observed after administration of the IP and up to the follow-up period. An AE was considered "serious" if the event: 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 (except for planned procedures as allowed per study) or leads to prolongation of hospitalization; Other medically important events.
  • Plasma Concentration of Pudexacianinium Chloride [ Time Frame: Predose, 10, 30, 60, 90, 120 minutes, end of surgery, 180 mins post dose ]
    Plasma concentration of pudexacianinium chloride was reported from the blood samples collected. Concentrations below the lower limit of quantification (1 nanogram per milliliter [ng/mL]) are set to zero.
  • Urine Concentration of Pudexacianinium Chloride [ Time Frame: Predose, 10, 30, 60, 90 minutes, end of surgery, 180 mins post dose ]
    Urine concentration of pudexacianinium chloride was reported from the urine samples collected. Concentrations below the lower limit of quantification (20 ng/mL) are set to zero.
  • Amount of Pudexacianinium Chloride Excreted in Urine (Ae) During Surgery [ Time Frame: During surgery (on day 1) ]
    Amount of pudexacianinium chloride excreted in urine during surgery was reported.
  • Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%) During Surgery [ Time Frame: During surgery (on day 1) ]
    Percentage of pudexacianinium chloride dose excreted into urine during surgery was reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
  • Number of participants with vital sign abnormalities and/or Adverse Events (AEs) [ Time Frame: Up to Day 7 ]
    Number of participants with potentially clinically significant vital sign values.
  • Number of participants with electrocardiogram (ECG) abnormalities and/or AEs [ Time Frame: Up to Day 7 ]
    Number of participants with potentially clinically significant 12-ECG values.
  • Number of participants with laboratory value abnormalities and/or AEs [ Time Frame: Up to Day 7 ]
    Number of participants with potentially clinically significant laboratory values.
  • Number of participants with Treatment Emergent Adverse Events (TEAEs) and serious adverse events [ Time Frame: Up to Day 7 ]
    A TEAE is defined as an AE observed after administration of the IP and up to the follow up period. An investigational product (IP)-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator. Adverse event (AE) is considered "serious" if, in the view of either the investigator or sponsor, the event: 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 hospitalization or prolongation to hospitalization, or other medically important event.
  • Pharmacokinetics (PK) of ASP5354 in plasma: concentration [ Time Frame: Up to end of surgery or 180 minutes after ASP5354 administration, whichever is later (Day 1) ]
    Concentration will be recorded from the PK plasma samples collected.
  • PK of ASP5354 in urine: concentration [ Time Frame: Up to end of surgery (Day 1) ]
    Concentration will be recorded from the PK urine samples collected.
  • PK of ASP5354: amount of ASP5354 excreted in urine (Ae) [ Time Frame: Up to end of surgery (Day 1) ]
    Ae will be recorded from the PK urine samples collected.
  • PK of ASP5354: Percentage of ASP5354 dose excreted into urine (Ae%) [ Time Frame: Up to end of surgery (Day 1) ]
    Ae(%) will be recorded from the PK urine samples collected.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery
Official Title  ICMJE A Phase 2 Randomized Open-label, Dose-ranging Study for Ureter Visualization Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery
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.
Detailed Description

Participants were randomly assigned at each dose level (dose A, B, C). During a standard minimally invasive surgery, visualization of the surgical field was assessed following the placement of the near infrared fluorescence (NIR F) imaging system proximal to the ureter of interest and then ASP5354 was administered.

Based on Visualization Review Committee (VRC) review of the initial 3 dose levels, if none of the doses selected had visualization, then additional two dose levels (dose D and E) was planned to be added; if 1 dose selected has visualization, then the dose level D was planned to be added. The dose level F was planned to be added if only the dose E level has visualization.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Laparoscopic/Minimally Invasive Colorectal Surgery
Intervention  ICMJE Drug: Pudexacianinium chloride
Intravenous
Other Name: ASP5354
Study Arms  ICMJE
  • Experimental: Pudexacianinium chloride - Dose Level A
    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.
    Intervention: Drug: Pudexacianinium chloride
  • Experimental: Pudexacianinium chloride - Dose Level B
    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.
    Intervention: Drug: Pudexacianinium chloride
  • Experimental: Pudexacianinium chloride - Dose Level C
    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.
    Intervention: Drug: Pudexacianinium chloride
  • Experimental: Pudexacianinium chloride - Dose Level B - Dose Expansion
    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.
    Intervention: Drug: Pudexacianinium chloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2023)
13
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2020)
45
Actual Study Completion Date  ICMJE November 29, 2021
Actual Primary Completion Date November 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.)
    • Serum bilirubin ≥ 2 × upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
    • Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
  • Subject has taken ICG or other near-infrared fluorescence (NIR)-F imaging agents within 48 hours prior to study treatment administration.
  • Subject has taken diuretics or inhibitors of renal transporters defined by Food and Drug Administration (FDA) within 48 hours prior to study treatment administration.
  • Subject has used any illicit drugs, unless legally prescribed and is not being abused (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 1 month prior to day -1.
  • Subject has a history of alcohol abuse. Subject should not have consumed any alcohol within 48 hours of surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04238481
Other Study ID Numbers  ICMJE 5354-CL-0201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Current Responsible Party Astellas Pharma Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Astellas Pharma Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP