Ovarian CancerPhase 3NCT03180307
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
A Phase 3 study testing OTL38, near infrared camera imaging system and laparotomy in people with Ovarian Cancer, run by On Target Laboratories, LLC at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- OTL38, near infrared camera imaging system and laparotomy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 26 Jan 2018to 16 Oct 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
Karmanos Cancer Institutes
Detroit, Michigan, 48201
City of Hope Medical Center
Duarte, California, 91010
Kettering Medical Center
Kettering, Ohio, 45427
University of CA at Irvine Chao Cancer Center
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
Mayo Clinic-Rochester
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63108
Moffitt Cancer Center
Tampa, Florida, 33612
University of Arizona
Tucson, Arizona, 85724
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
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
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.
Read the 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
- Conditions
- Ovarian Cancer
- Being tested
- OTL38, near infrared camera imaging system, laparotomy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTL38Drug
Also called OTL38 for Injection
0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
near infrared camera imaging systemDevice
Also called Near IR imaging
Infrared imaging used to excite OTL38 for fluorescence
laparotomyProcedure or surgery
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
| Study group | Role | What they receive |
|---|---|---|
| no fluorescent imaging | Sham comparator | Patient injected with OTL38, but does not undergo fluorescent imaging Receives: Drug: OTL38; Procedure: laparotomy |
| near infrared imaging arm | Experimental | Patient injected with OTL38 and undergoes near infrared imaging Receives: Drug: OTL38; Device: near infrared camera imaging system; Procedure: laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (1)
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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start26 Jan 2018
- Primary completion16 Apr 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- On Target Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SynteractHCR
- Responsible party
- Sponsor
- Investigators
- Janos Tanyi, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180307
- Sponsor's protocol ID
- OTL-2016-OTL38-006
- Status last verified
- Jan 2022
- First submitted
- 6 Jun 2017
- Last updated
- 4 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36070540
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03180307
- Acronym / sponsor ID
- OTL-2016-OTL38-006
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- On Target Laboratories, LLCIndustry (pharma, biotech, devices)
- Collaborators
- SynteractHCR
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Posted 4 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no fluorescent imaging | Sham comparator | Drug: OTL38, Procedure: laparotomyPatient injected with OTL38, but does not undergo fluorescent imaging |
| near infrared imaging arm | Experimental | Drug: OTL38, Device: near infrared camera imaging system, Procedure: laparotomyPatient injected with OTL38 and undergoes near infrared imaging |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTL38Also: OTL38 for Injection0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes | Drug | near infrared imaging arm, no fluorescent imaging |
| near infrared camera imaging systemAlso: Near IR imagingInfrared imaging used to excite OTL38 for fluorescence | Device | near infrared imaging arm |
| laparotomyprimary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery | Procedure or surgery | near infrared imaging arm, no fluorescent imaging |
Primary outcome
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)
1 secondary outcome
Patient False Positive Rate
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36070540Tanyi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janos Tanyi, MD principal investigator
University of Pennsylvania
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OTL38, near infrared camera imaging system and laparotomy in people with Ovarian Cancer, run by On Target Laboratories, LLC at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Patient Level (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03180307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.