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

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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: OTL38; Procedure: laparotomy; Device: near infrared camera imaging system

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
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • South Holland
    • Leiden, South Holland, Netherlands, 2333 ZA
      • Leiden University Medical Center
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • The Mayo Clinic - Phoenix
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
    • Orange, California, United States, 92868
      • University of CA at Irvine Chao Cancer Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institutes
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic-Rochester
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School of Medicine
  • Ohio
    • Kettering, Ohio, United States, 45427
      • Kettering Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: no fluorescent imaging; Patient injected with OTL38, but does not undergo fluorescent imaging	Drug: OTL38; 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes; Other Names: OTL38 for Injection; Procedure: laparotomy; primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Experimental: near infrared imaging arm; Patient injected with OTL38 and undergoes near infrared imaging	Drug: OTL38; 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes; Other Names: OTL38 for Injection; Procedure: laparotomy; primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery; Device: near infrared camera imaging system; Infrared imaging used to excite OTL38 for fluorescence; Other Names: Near IR imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Patient Level	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)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient False Positive Rate	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)	30 days

Collaborators and Investigators

• Sponsor: On Target Laboratories, LLC
• Collaborators: SynteractHCR
• Investigators: Principal Investigator: Janos Tanyi, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): April 16, 2020
• Study Completion (Actual): October 16, 2020

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: OTL-2016-OTL38-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes