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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
OTL38
near infrared camera imaging system
laparotomy
Sponsored by
On Target Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ovarian Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Mayo Clinic - Phoenix
  • University of Arizona
  • City of Hope Medical Center
  • University of CA at Irvine Chao Cancer Center
  • Moffitt Cancer Center
  • Karmanos Cancer Institutes
  • Mayo Clinic-Rochester
  • Washington University School of Medicine
  • Kettering Medical Center
  • University of Pennsylvania
  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

no fluorescent imaging

near infrared imaging arm

Arm Description

Patient injected with OTL38, but does not undergo fluorescent imaging

Patient injected with OTL38 and undergoes near infrared imaging

Outcomes

Primary Outcome Measures

Efficacy Patient Level
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

Patient False Positive Rate
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)

Full Information

First Posted
June 6, 2017
Last Updated
January 7, 2022
Sponsor
On Target Laboratories, LLC
Collaborators
SynteractHCR
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1. Study Identification

Unique Protocol Identification Number
NCT03180307
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
April 16, 2020 (Actual)
Study Completion Date
October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
On Target Laboratories, LLC
Collaborators
SynteractHCR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no fluorescent imaging
Arm Type
Sham Comparator
Arm Description
Patient injected with OTL38, but does not undergo fluorescent imaging
Arm Title
near infrared imaging arm
Arm Type
Experimental
Arm Description
Patient injected with OTL38 and undergoes near infrared imaging
Intervention Type
Drug
Intervention Name(s)
OTL38
Other Intervention Name(s)
OTL38 for Injection
Intervention Description
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
Intervention Type
Device
Intervention Name(s)
near infrared camera imaging system
Other Intervention Name(s)
Near IR imaging
Intervention Description
Infrared imaging used to excite OTL38 for fluorescence
Intervention Type
Procedure
Intervention Name(s)
laparotomy
Intervention Description
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Primary Outcome Measure Information:
Title
Efficacy Patient Level
Description
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)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Patient False Positive Rate
Description
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)
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janos Tanyi, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mayo Clinic - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of CA at Irvine Chao Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Karmanos Cancer Institutes
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic-Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45427
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
South Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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