Phase 3 study with OTL38 in ovarian cancer
- Conditions
- Ovarian cancer
- Registration Number
- NL-OMON27574
- Lead Sponsor
- On Target Laboratories, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
1. Female patients 18 years of age and older
2. 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:
o Who are scheduled to undergo laparotomy for the debulking surgery OR
o Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy
3. 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.
4. 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
5. 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.
1. Previous exposure to OTL38
2. Known FR-negative ovarian cancer
3. Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
4. Patients with known ovarian cancer miliary disease prior to surgery
5. Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the
patient
6. History of anaphylactic reactions
7. History of allergy to any of the components of OTL38, including folic acid
8. Pregnancy or positive pregnancy test
9. Clinically significant abnormalities on electrocardiogram (ECG)
10.Presence of any psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule
11.Impaired renal function defined as eGFR< 50 mL/min/1.73m2
12.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.
13.Known Stage IV ovarian cancer with brain metastases
14.Received an investigational agent in another clinical trial within 30 days prior to surgery
15.Known sensitivity to fluorescent light
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • 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. All evaluable FR+ ovarian cancer lesions that were identified prior to or after surgery, that were detected using the combination of OTL38 and fluorescent light but not under normal light or palpation, and were removed based on the evaluation under fluorescent light, will be included in the calculation of the proportion of patients with at least one FR+ ovarian cancer lesion confirmed by central pathology. The primary endpoint will be determined based on evaluable lesions as described below.<br>• Evaluable lesions are defined as follows: lesions that do not appear on an organ or tissue that was intended for removal based on the Pre-Fluorescence Surgical Plan, regardless of the absence or presence of tumor.<br>
- Secondary Outcome Measures
Name Time Method