search
Back to results

Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)

Primary Purpose

Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gleolan
Sponsored by
NX Development Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer focused on measuring ALA, Fluorescence guided surgery, Gleolan, Ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Study will be limited to patients with the following diagnoses who plan to undergo surgical cytoreduction or interval debulking: a. primary diagnosis or high clinical suspicion of primary epithelial ovarian cancer, b. suspected epithelial, peritoneal, or fallopian tube cancer, c. recurrent epithelial ovarian cancer. Note: participants with a diagnosis of (a) or (b) may be treatment-naïve or have received neoadjuvant therapy, as clarified in Exclusion Criteria 6 and 9. A pre-operative magnetic resonance image (MRI), positron emission tomography (PET), or computed tomography (CT) ≤ 30 days of study enrollment documenting a suspected tumor or suspected recurrence of tumor for which surgical debulking is indicated and has been planned. Females (only) age ≥ 18 years. Study participants must have normal organ and bone marrow function and be appropriate surgical candidates per site SoC. Study participant must have recording of each parameter as defined below: Bilirubin: Below upper limit of normal AST (SGOT): < 2.5 X institutional upper limit of normal ALT (SGPT): < 2.5 X institutional upper limit of normal Creatinine: Below upper limit of normal OR Creatinine clearance: >60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal The study subject t must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and Spanish. Translation for non-English speaking participants will be provided as appropriate by institution, as required. Women of childbearing potential must agree to use highly effective forms of contraception for at least 42 days after the one-time use of the Gleolan study drug. Exclusion Criteria: Patient is to undergo laparoscopy and their surgeon believes it is unlikely that laparotomy/debulking will occur. Hypersensitivity to aminolevulenic acid (ALA) or porphyrins. Acute or chronic types of porphyria. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness. Patient has had chemotherapy, tumor resection or radiation treatment within 21 days prior to surgery. Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI, PET, or CT. Women who are pregnant or plan to become pregnant during study participation. Simultaneous participation in another investigational treatment trial in the 21 days directly preceding or after study drug administration. Simultaneous use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period. Unwillingness by study participant to sign consent or return for subsequent visits following surgery. Any condition that in the opinion of the Investigator would exclude the study participant as a viable candidate for this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients Receiving Gleolan

    Arm Description

    All patients in this arm will receive Gleolan and undergo intraoperative imaging

    Outcomes

    Primary Outcome Measures

    To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery.
    Percentage of participants with at least one suspected ovarian cancer lesion (including lymph nodes) where Gleolan-induced FL is confirmed by central histopathology (Standard of Truth) to be tumor that was not detected during SoC debulking, among all participants who meet the eligibility criteria for the study and receive any amount of Gleolan.

    Secondary Outcome Measures

    To determine the biopsy-level PPV (i.e., diagnostic performance) of Gleolan for the real-time visualization of newly diagnosed or recurrent epithelial ovarian cancer during debulking surgery.
    Positive Predictive Value (PPV) of Gleolan-induced FL among biopsies obtained from each study participant following SoC debulking surgery.

    Full Information

    First Posted
    March 27, 2023
    Last Updated
    March 27, 2023
    Sponsor
    NX Development Corp
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05804370
    Brief Title
    Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
    Official Title
    A Phase 3 Multicenter Study of Gleolan™ (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Suspected Newly Diagnosed or Recurrent Epithelial Ovarian Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NX Development Corp

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking.
    Detailed Description
    This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking. Gleolan is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The oral provision of Gleolan leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (wavelength [λ] = 375 - 450 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light. This phenomenon provides the surgeon with real-time fluorescence (FL) visualization of malignant tissue during cancer resection surgery, which would otherwise not be readily visible to the naked eye. Patients pending resection for suspected epithelial ovarian cancer (Stage I-IV) will sign an informed consent and will be screened to assess study eligibility. Ovarian cancer patients with newly diagnosed disease and those with recurrent disease deemed medically eligible for tumor debulking surgery will be considered for participation. Study participants who are either treatment naïve or have received adjuvant therapy and/or interval debulking and allowed a minimum 21-day waiting period since last treatment are eligible for enrollment. Study participants will be evaluated within 48 hours post-procedure and 2 weeks post-procedure for study safety assessment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer
    Keywords
    ALA, Fluorescence guided surgery, Gleolan, Ovarian cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    170 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients Receiving Gleolan
    Arm Type
    Experimental
    Arm Description
    All patients in this arm will receive Gleolan and undergo intraoperative imaging
    Intervention Type
    Drug
    Intervention Name(s)
    Gleolan
    Intervention Description
    Gleolan is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The oral provision of Gleolan leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (wavelength [λ] = 375 - 450 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light.
    Primary Outcome Measure Information:
    Title
    To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery.
    Description
    Percentage of participants with at least one suspected ovarian cancer lesion (including lymph nodes) where Gleolan-induced FL is confirmed by central histopathology (Standard of Truth) to be tumor that was not detected during SoC debulking, among all participants who meet the eligibility criteria for the study and receive any amount of Gleolan.
    Time Frame
    Surgery (Day 1)
    Secondary Outcome Measure Information:
    Title
    To determine the biopsy-level PPV (i.e., diagnostic performance) of Gleolan for the real-time visualization of newly diagnosed or recurrent epithelial ovarian cancer during debulking surgery.
    Description
    Positive Predictive Value (PPV) of Gleolan-induced FL among biopsies obtained from each study participant following SoC debulking surgery.
    Time Frame
    Surgery (Day 1)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Study will be limited to patients with the following diagnoses who plan to undergo surgical cytoreduction or interval debulking: a. primary diagnosis or high clinical suspicion of primary epithelial ovarian cancer, b. suspected epithelial, peritoneal, or fallopian tube cancer, c. recurrent epithelial ovarian cancer. Note: participants with a diagnosis of (a) or (b) may be treatment-naïve or have received neoadjuvant therapy, as clarified in Exclusion Criteria 6 and 9. A pre-operative magnetic resonance image (MRI), positron emission tomography (PET), or computed tomography (CT) ≤ 30 days of study enrollment documenting a suspected tumor or suspected recurrence of tumor for which surgical debulking is indicated and has been planned. Females (only) age ≥ 18 years. Study participants must have normal organ and bone marrow function and be appropriate surgical candidates per site SoC. Study participant must have recording of each parameter as defined below: Bilirubin: Below upper limit of normal AST (SGOT): < 2.5 X institutional upper limit of normal ALT (SGPT): < 2.5 X institutional upper limit of normal Creatinine: Below upper limit of normal OR Creatinine clearance: >60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal The study subject t must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and Spanish. Translation for non-English speaking participants will be provided as appropriate by institution, as required. Women of childbearing potential must agree to use highly effective forms of contraception for at least 42 days after the one-time use of the Gleolan study drug. Exclusion Criteria: Patient is to undergo laparoscopy and their surgeon believes it is unlikely that laparotomy/debulking will occur. Hypersensitivity to aminolevulenic acid (ALA) or porphyrins. Acute or chronic types of porphyria. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness. Patient has had chemotherapy, tumor resection or radiation treatment within 21 days prior to surgery. Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI, PET, or CT. Women who are pregnant or plan to become pregnant during study participation. Simultaneous participation in another investigational treatment trial in the 21 days directly preceding or after study drug administration. Simultaneous use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period. Unwillingness by study participant to sign consent or return for subsequent visits following surgery. Any condition that in the opinion of the Investigator would exclude the study participant as a viable candidate for this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ASHLEY COX, MBA
    Phone
    502-316-8981
    Email
    acox@nxdevcorp.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ron Mims
    Phone
    505-681-3537
    Email
    rmims@nxdevcorp.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristina Butler, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John McBroom, MD
    Organizational Affiliation
    Luminis Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)

    We'll reach out to this number within 24 hrs