OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

• 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: On Target Laboratories, LLC
• Collaborator: SynteractHCR
• Information provided by (Responsible Party): On Target Laboratories, LLC

Tracking Information

• First Submitted Date: June 6, 2017
• First Posted Date: June 8, 2017
• Results First Submitted Date: October 14, 2021
• Results First Posted Date: February 4, 2022
• Last Update Posted Date: February 4, 2022
• Actual Study Start Date: January 26, 2018
• Actual Primary Completion Date: April 16, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Ovarian Cancer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 3, 2021): 140
• Original Estimated Enrollment (submitted: June 6, 2017): 147
• Actual Study Completion Date: October 16, 2020
• Actual Primary Completion Date: April 16, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands, United States

Administrative Information

• NCT Number: NCT03180307
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: On Target Laboratories, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: On Target Laboratories, LLC
• Original Study Sponsor: Same as current
• Collaborators: SynteractHCR

Investigators

• Principal Investigator: Janos Tanyi, MD; University of Pennsylvania

• PRS Account: On Target Laboratories, LLC
• Verification Date: January 2022