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Trial record 1 of 1 for:    NCT03180307.
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OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03180307
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Collaborator:
SynteractHCR
Information provided by (Responsible Party):
On Target Laboratories, LLC

Tracking Information
First Submitted Date  ICMJE June 6, 2017
First Posted Date  ICMJE June 8, 2017
Results First Submitted Date  ICMJE October 14, 2021
Results First Posted Date  ICMJE February 4, 2022
Last Update Posted Date February 4, 2022
Actual Study Start Date  ICMJE January 26, 2018
Actual Primary Completion Date April 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2021)
Efficacy Patient Level [ Time Frame: 30 days ]
Percentage of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation (Full Analysis Set)
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2017)
Efficacy patient level [ Time Frame: 30 days ]
• Proportion of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2021)
Patient False Positive Rate [ Time Frame: 30 days ]
False Positive Rate at the patient level (FPRp) will be a major secondary efficacy endpoint and is defined as the percentage of women who underwent both normal light and fluorescent light (Intent-to-Image Set)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2017)
Patient false positive rate [ Time Frame: 30 days ]
• False Positive Rate at the patient level (FPRp) will be a major secondary efficacy endpoint and is defined as the proportion of folate positive ovarian cancer patients in whom all lesions, without regard to evaluable lesion status, detected by fluorescent light only, are histologically negative
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Official Title  ICMJE A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Brief Summary This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.
Detailed Description The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: OTL38
    0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
    Other Name: OTL38 for Injection
  • Device: near infrared camera imaging system
    Infrared imaging used to excite OTL38 for fluorescence
    Other Name: Near IR imaging
  • Procedure: laparotomy
    primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Study Arms  ICMJE
  • Sham Comparator: no fluorescent imaging
    Patient injected with OTL38, but does not undergo fluorescent imaging
    Interventions:
    • Drug: OTL38
    • Procedure: laparotomy
  • Experimental: near infrared imaging arm
    Patient injected with OTL38 and undergoes near infrared imaging
    Interventions:
    • Drug: OTL38
    • Device: near infrared camera imaging system
    • Procedure: laparotomy
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: December 3, 2021)
140
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2017)
147
Actual Study Completion Date  ICMJE October 16, 2020
Actual Primary Completion Date April 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients 18 years of age and older
  • Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and:

    • Who are scheduled to undergo laparotomy for the debulking surgery OR
    • Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy
  • A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
  • Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
  • Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

  • Previous exposure to OTL38
  • Known FR-negative ovarian cancer
  • Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
  • Patients with known ovarian cancer miliary disease determined preoperatively to be inoperable.
  • Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient
  • History of anaphylactic reactions
  • History of allergy to any of the components of OTL38, including folic acid
  • Pregnancy or positive pregnancy test
  • Clinically significant abnormalities on electrocardiogram (ECG)
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Impaired renal function defined as eGFR< 50 mL/min/1.73m2
  • Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
  • Known Stage IV ovarian cancer with brain metastases
  • Received an investigational agent in another clinical trial within 30 days prior to surgery
  • Known sensitivity to fluorescent light
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 85 Years   (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 Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03180307
Other Study ID Numbers  ICMJE OTL-2016-OTL38-006
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: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party On Target Laboratories, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE On Target Laboratories, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE SynteractHCR
Investigators  ICMJE
Principal Investigator: Janos Tanyi, MD University of Pennsylvania
PRS Account On Target Laboratories, LLC
Verification Date January 2022

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