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History of Changes for Study: NCT03180307
Phase 3 Study of OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Latest version (submitted January 7, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 6, 2017 None (earliest Version on record)
2 June 8, 2017 Study Status and Study Identification
3 January 26, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 April 9, 2018 Study Design, Study Status and Contacts/Locations
5 January 8, 2019 Study Status and Contacts/Locations
6 August 28, 2019 Study Status, Contacts/Locations, Eligibility and Study Design
7 August 5, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 December 5, 2020 Recruitment Status and Study Status
9 September 15, 2021 Arms and Interventions, Study Design, Study Status and Eligibility
10 October 14, 2021
Quality Control Review has not concluded Returned: November 11, 2021
Outcome Measures, Study Status, Document Section
11 December 3, 2021
Quality Control Review has not concluded Returned: December 30, 2021
Outcome Measures, Adverse Events, Participant Flow, Study Status and Study Design
12 January 7, 2022 Study Status, Outcome Measures
Comparison Format:

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Study NCT03180307
Submitted Date:  June 6, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: OTL-2016-OTL38-006
Brief Title: Phase 3 Study of 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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Not yet recruiting
Study Start: September 2017
Primary Completion: July 2018 [Anticipated]
Study Completion: November 2018 [Anticipated]
First Submitted: June 6, 2017
First Submitted that
Met QC Criteria:
June 6, 2017
First Posted: June 8, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 6, 2017
Last Update Posted: June 8, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: On Target Laboratories, LLC
Responsible Party: Sponsor
Collaborators: SynteractHCR
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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
Open or close this module Conditions
Conditions: Ovarian Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
95% randomized to near infrared imaging arm and 5% randomized to sham arm
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 147 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • 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 Names:
  • OTL38 for Injection
Device: near infrared imaging
Infrared imaging used to excite OTL38 for fluorecence
Other Names:
  • Near IR imaging
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 85 Years
Sex: Female
Gender Based:
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

Open or close this module Contacts/Locations
Central Contact Person: Timothy Biro, MBA
Telephone: 2165333082
Email: tgboif@gmail.com
Central Contact Backup: Aaron Blouin, BA
Telephone: 215-908-5866
Email: Ablouin@ontargetlabs.com
Study Officials: Janos Tanyi, MD
Principal Investigator
University of Pennsylvania
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services