NCT03180307

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

Completed Phase 3 Results posted Last updated 4 February 2022

What this trial tests

Phase 3 trial testing OTL38 in Ovarian Cancer in 140 participants. Completed in 16 October 2020.

Timeline

26 January 2018

Primary endpoint
16 April 2020

16 October 2020

Quick facts

Lead sponsor	On Target Laboratories, LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	140
Start date	26 January 2018
Primary completion	16 April 2020
Estimated completion	16 October 2020
Sites	11 locations across Netherlands, United States

Drugs / interventions tested

• OTL38 — full drug profile →
• near infrared camera imaging system
• laparotomy

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

On Target Laboratories, LLC — full company profile →

Who can join

Adults 18 to 85, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Efficacy Patient Level Primary · 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)

Group	Value	95% CI
Full Analysis Set	26.9	19.6 – 35.2

Patient False Positive Rate Secondary · 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)

Group	Value	95% CI
Full Analysis Set	20.2	13.7 – 28.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Safety Analysis Set

Serious: 22/150 (15%)

Deaths: 2/150

Serious adverse events (31 terms)

Reaction	System	Safety Analysis Set
Postoperative ileus	Injury, poisoning and procedural complications	—
Acute kidney injury	Renal and urinary disorders	—
Septic shock	Infections and infestations	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—
Abscess	Infections and infestations	—
Clostridium difficile infection	Infections and infestations	—
Peritonitis	Infections and infestations	—
Pneumonia	Infections and infestations	—
Postoperative wound infection	Immune system disorders	—
Sepsis	Infections and infestations	—
Anastomotic leak	Injury, poisoning and procedural complications	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—
Vaginal cuff dehiscence	Injury, poisoning and procedural complications	—
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Diverticular perforation	Gastrointestinal disorders	—
Gastric perforation	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—
Hyponatraemia	Metabolism and nutrition disorders	—
Metabolic acidosis	Metabolism and nutrition disorders	—
Renal impairment	Renal and urinary disorders	—
Sinus tachycardia	Cardiac disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Safety Analysis Set
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Abdominal pain	Gastrointestinal disorders	—

Most-reported serious reactions: Postoperative ileus, Acute kidney injury, Septic shock, Pleural effusion, Abscess, Clostridium difficile infection, Peritonitis, Pneumonia.

Data from ClinicalTrials.gov NCT03180307 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006).
   Tanyi JL, Randall LM, Chambers SK, Butler KA, et al · · 2023 · cited 122× · PMID 36070540 · DOI 10.1200/jco.22.00291
2. FolamiRs: Ligand-targeted, vehicle-free delivery of microRNAs for the treatment of cancer.
   Orellana EA, Tenneti S, Rangasamy L, Lyle LT, et al · · 2017 · cited 81× · PMID 28768807 · DOI 10.1126/scitranslmed.aam9327
3. Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
   Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292
4. Single- versus Dual-Targeted Nanoparticles with Folic Acid and Biotin for Anticancer Drug Delivery.
   Jurczyk M, Jelonek K, Musiał-Kulik M, Beberok A, et al · · 2021 · cited 71× · PMID 33802531 · DOI 10.3390/pharmaceutics13030326
5. Folate Receptor Alpha-A Novel Approach to Cancer Therapy.
   Gonzalez T, Muminovic M, Nano O, Vulfovich M. · · 2024 · cited 52× · PMID 38256120 · DOI 10.3390/ijms25021046
6. Fluorescence Guidance in Surgical Oncology: Challenges, Opportunities, and Translation.
   Olson MT, Ly QP, Mohs AM. · · 2019 · cited 48× · PMID 29942988 · DOI 10.1007/s11307-018-1239-2
7. Intraoperative molecular imaging clinical trials: a review of 2020 conference proceedings.
   Azari F, Kennedy G, Bernstein E, Hadjipanayis C, et al · · 2021 · cited 35× · PMID 34002555 · DOI 10.1117/1.jbo.26.5.050901
8. Intraoperative molecular imaging: 3rd biennial clinical trials update.
   Bou-Samra P, Muhammad N, Chang A, Karsalia R, et al · · 2023 · cited 31× · PMID 37193364 · DOI 10.1117/1.jbo.28.5.050901