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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180307
• Other study ID #: OTL-2016-OTL38-006
• Status: Completed
• Phase: Phase 3
• Start date: January 26, 2018
• Est. completion date: October 16, 2020

Study information

• Verified date: January 2022
• Source: On Target Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 16, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• OTL38
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes

Device:
• near infrared camera imaging system
Infrared imaging used to excite OTL38 for fluorescence

Procedure:
• laparotomy
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	South Holland
United States	Karmanos Cancer Institutes	Detroit	Michigan
United States	City of Hope Medical Center	Duarte	California
United States	Kettering Medical Center	Kettering	Ohio
United States	University of CA at Irvine Chao Cancer Center	Orange	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Mayo Clinic - Phoenix	Phoenix	Arizona
United States	Mayo Clinic-Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Moffitt Cancer Center	Tampa	Florida
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
On Target Laboratories, LLC	SynteractHCR

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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