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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180307
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Collaborator:
SynteractHCR
Information provided by (Responsible Party):
On Target Laboratories, LLC

Study Description
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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 camera imaging system Procedure: laparotomy 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Actual Primary Completion Date : April 16, 2020
Actual Study Completion Date : October 16, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 dextrose 5% in water (D5W) infused intravenously over 60 minutes
Other Name: OTL38 for Injection

Procedure: laparotomy
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Experimental: near infrared imaging arm
Patient injected with OTL38 and undergoes near infrared imaging
 Drug: OTL38
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
Other Name: OTL38 for Injection

Device: near infrared camera imaging system
Infrared imaging used to excite OTL38 for fluorescence
Other Name: Near IR imaging

Procedure: laparotomy
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy Patient Level [ Time Frame: 30 days ]
    Percentage 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 (Full Analysis Set)


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 percentage of women who underwent both normal light and fluorescent light (Intent-to-Image Set)


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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


Locations
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United States, Arizona
The Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
University of CA at Irvine Chao Cancer Center
Orange, California, United States, 92868
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
Karmanos Cancer Institutes
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic-Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63108
United States, Ohio
Kettering Medical Center
Kettering, Ohio, United States, 45427
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Sponsors and Collaborators
On Target Laboratories, LLC
SynteractHCR
Investigators
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Principal Investigator: Janos Tanyi, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by On Target Laboratories, LLC:
Study Protocol  [PDF] November 27, 2018
Statistical Analysis Plan  [PDF] May 16, 2017

More Information
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Responsible Party: On Target Laboratories, LLC
ClinicalTrials.gov Identifier: NCT03180307    
Other Study ID Numbers: OTL-2016-OTL38-006
First Posted: June 8, 2017    Key Record Dates
Results First Posted: February 4, 2022
Last Update Posted: February 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type