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

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ClinicalTrials.gov Identifier: NCT03180307
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
SynteractHCR
Information provided by (Responsible Party):
On Target Laboratories, LLC

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: OTL38 Device: near infrared imaging Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Sham Comparator: no fluorescent imaging
Patient injected with OTL38, but does not undergo fluorescent imaging
Drug: OTL38
0.025 mg/kg of OTL38 in 250ml D5W infused intravenously over 60 minutes
Other Name: OTL38 for Injection

Experimental: near infrared imaging arm
Patient injected with OTL38 and undergoes near infrared imaging
Drug: OTL38
0.025 mg/kg of OTL38 in 250ml D5W infused intravenously over 60 minutes
Other Name: OTL38 for Injection

Device: near infrared imaging
Infrared imaging used to excite OTL38 for fluorecence
Other Name: Near IR imaging




Primary Outcome Measures :
  1. Efficacy patient level [ Time Frame: 30 days ]
    • 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


Secondary Outcome Measures :
  1. Patient false positive rate [ Time Frame: 30 days ]
    • 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180307


Contacts
Contact: Timothy Biro, MBA 2165333082 tgboif@gmail.com
Contact: Aaron Blouin, BA 215-908-5866 Ablouin@ontargetlabs.com

Locations
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact: Research Coordinator    520-694-9071      
Principal Investigator: Setsuko Chambers, M.D         
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Research Coordinator    626-218-1133      
Principal Investigator: Ernest Han, M.D., Ph.D.         
University of CA at Irvine Chao Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Leslie Randall, MD    714-456-7971    lrandall@uci.edu   
Principal Investigator: Leslie Randall, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Robert Wenham, MD    813-745-4933      
Principal Investigator: Robert Wenham, MD         
United States, Maryland
Mercy Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21202
Contact: Michelle Sittig       msittig@mdmercy.org   
Principal Investigator: Teresa Diaz-Montes, MD, MPH         
United States, Michigan
Karmanos Cancer Institutes Recruiting
Detroit, Michigan, United States, 48201
Contact: Research Coordinator    313-576-8994      
Principal Investigator: Ira Winer, M.D., Ph.D.         
United States, Minnesota
Mayo Clinic-Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Maureen Lemens, MD    507-293-1487    Lemens.Maureen@mayo.edu   
Principal Investigator: Carrie Langstraat, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Research Coordinator    314-362-2288      
Principal Investigator: Premal Thaker, M.D         
United States, Ohio
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45427
Contact: Allison Streifthau, BSN, RN       Allison.Streifthau@ketteringhealth.org   
Principal Investigator: Thomas Reid, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Janos L Tanyi, MD, PhD    267-279-7255      
Principal Investigator: Janos Tanyi, MD         
Sponsors and Collaborators
On Target Laboratories, LLC
SynteractHCR
Investigators
Principal Investigator: Janos Tanyi, MD University of Pennsylvania

Responsible Party: On Target Laboratories, LLC
ClinicalTrials.gov Identifier: NCT03180307     History of Changes
Other Study ID Numbers: OTL-2016-OTL38-006
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type