Clinical trial NCT03180307: OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Lead sponsor: On Target Laboratories, LLC
Sponsor class: INDUSTRY
Collaborators: name: SynteractHCR
First posted: 2017-06-08
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy Patient Level
timeFrame: 30 days
Secondary outcomes:
measure: Patient False Positive Rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The Mayo Clinic - Phoenix
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Orange
country: United States
facility: University of CA at Irvine Chao Cancer Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Detroit
country: United States
facility: Karmanos Cancer Institutes
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South Holland
Study officials:
affiliation: University of Pennsylvania
name: Janos Tanyi, MD
role: PRINCIPAL_INVESTIGATOR
References: