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

NCT03180307 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: OTL-2016-OTL38-006
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 11

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days

Secondary Outcomes (1)

• Patient False Positive Rate

  30 days

Study Arms (2)

no fluorescent imaging

SHAM COMPARATOR

Patient injected with OTL38, but does not undergo fluorescent imaging

Drug: OTL38; Procedure: laparotomy

near infrared imaging arm

EXPERIMENTAL

Patient injected with OTL38 and undergoes near infrared imaging

Drug: OTL38; Device: near infrared camera imaging system; Procedure: laparotomy

Interventions

OTL38 DRUG

0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes

Also known as: OTL38 for Injection

near infrared imaging arm; no fluorescent imaging

near infrared camera imaging system DEVICE

Infrared imaging used to excite OTL38 for fluorescence

Also known as: Near IR imaging

near infrared imaging arm

laparotomy PROCEDURE

primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

near infrared imaging arm; no fluorescent imaging

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• On Target Laboratories, LLC: lead
• SynteractHCR: collaborator

Study Sites (11)

The Mayo Clinic - Phoenix

Phoenix, Arizona, 85054, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

University of CA at Irvine Chao Cancer Center

Orange, California, 92868, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Karmanos Cancer Institutes

Detroit, Michigan, 48201, United States

Location

Mayo Clinic-Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Kettering Medical Center

Kettering, Ohio, 45427, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

• Tanyi JL, Randall LM, Chambers SK, Butler KA, Winer IS, Langstraat CL, Han ES, Vahrmeijer AL, Chon HS, Morgan MA, Powell MA, Tseng JH, Lopez AS, Wenham RM. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006). J Clin Oncol. 2023 Jan 10;41(2):276-284. doi: 10.1200/JCO.22.00291. Epub 2022 Sep 7.

  PMID: 36070540 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Pafolacianine; Injections; Laparotomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Tommy Lee, MSHS, Vice President, Clinical Operations
• Organization: On Target Laboratories

Tlee@ontargetlabs.com

765-588-4547

Study Officials

• Janos Tanyi, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: January 26, 2018
• Primary Completion: April 16, 2020
• Study Completion: October 16, 2020
• Last Updated: February 4, 2022
• Results First Posted: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); US (10)