Ovarian cancer MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: OTL38
Product Code: OTL38
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N.A.
CAS Number: N.A.
Current Sponsor code: OTL-038
Other descriptive name: OTL0038
Concentrati
Sponsors
On Target Laboratories, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below: 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, 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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients will be excluded if they meet any of the exclusion criteria listed below: 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 the 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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;Secondary Objective: • 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 ;Primary end point(s): Primary Efficacy • 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. • Evaluable lesions are defined as follows: lesions that do not appear on an organ or tissue that was intended for removal based on;Timepoint(s) of evaluation of this end point: Day 1 - Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 1 - Day 28;Secondary end point(s): Secondary Efficacy • 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.Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and ovarian cancer by central pathology relative to the total number of lesions confirmed to be FR+ and ovarian cancer by central pathology without regard to evaluable lesion status. From the classification table below: TP/TP+FN • False positive rate (FPR) for OTL38 in combination with fluorescent light, for the purpose of this protocol, will be calculated as 1 – the Positive Predictive Value (PPV) and is defined as the proportion of fluorescent light positive lesions removed that are histologically confirmed to be non-cancerous, or if cancerous, not FR+ and ovarian cancer, by central pathology relative to the total number of lesions removed with fluorescent light imaging without regard to evaluable lesion status. From the classification table below: FP/TP+FP. | — |
Countries
Netherlands, United States
Contacts
Public ContactPrincipal Investigator
LUMC
Outcome results
None listed