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Clinical Trial 19421

Cancer Type:
Interventions:OTL38

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Robert Wenham

Overview

Study 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

Summary

The purpose of this study is to see if OTL38 helps light up the cancer when viewed with the special camera system; to test the safety of OTL38 to see if participants can tolerate it; and to test the safety of the special camera system for use along with OTL38 during surgery.

Objective

4.1 Primary: 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. 4.2 Secondary: To estimate 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, the patient level False Positive Rate (FPRp). To estimate the Sensitivity and False Positive Rate for OTL38 in combination with fluorescent light with respect to the detection of FR+ ovarian cancer lesions confirmed by central pathology. To assess the safety of using OTL38 and Visionsense VS3 Imaging System for intraoperative imaging with OTL38. 4.3 Exploratory: To estimate the lesion inoperability rate for all lesions identified by fluorescent light only. To describe the diagnostic characteristics of OTL38 in combination with fluorescent light for lesions of various histological and pathological cell types. To assess CA-125 levels before and after surgery. To estimate the plasma pharmacokinetics (PK) of OTL38 in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.

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 participants 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.
  • Known ovarian cancer miliary disease prior to surgery
  • Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the participant
  • 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 less than> 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