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



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 85
Updated:1/11/2019
Start Date:January 26, 2018
End Date:November 2019
Contact:Timothy Biro, MBA
Email:tgboif@gmail.com
Phone:2165333082

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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

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.

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

Inclusion Criteria:

- 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:

- 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

Exclusion Criteria:

- 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
We found this trial at
10
sites
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Principal Investigator: Teresa Diaz-Montes, MD, MPH
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Detroit, Michigan 48201
Principal Investigator: Ira Winer, M.D., Ph.D.
Phone: 313-576-8994
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Detroit, MI
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Duarte, California 91010
Principal Investigator: Ernest Han, M.D., Ph.D.
Phone: 626-218-1133
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Duarte, CA
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Principal Investigator: Thomas Reid, MD
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Orange, California 92868
Principal Investigator: Leslie Randall, MD
Phone: 714-456-7971
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Orange, CA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Janos Tanyi, MD
Phone: 267-279-7255
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Carrie Langstraat, MD
Phone: 507-293-1487
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Premal Thaker, M.D
Phone: 314-362-2288
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Tampa, Florida 33612
Principal Investigator: Robert Wenham, MD
Phone: 813-745-4933
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Tampa, FL
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Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Setsuko Chambers, M.D
Phone: 520-694-9071
University of Arizona The University of Arizona is a premier, public research university. Established in...
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