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

• ClinicalTrials.gov Identifier: NCT03180307
• Recruitment Status: Completed
• First Posted: June 8, 2017
• Results First Posted: February 4, 2022
• Last Update Posted: February 4, 2022
• Sponsor: On Target Laboratories, LLC
• Collaborator: SynteractHCR
• Information provided by (Responsible Party): On Target Laboratories, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Ovarian Cancer
• Interventions: Drug: OTL38; Device: near infrared camera imaging system; Procedure: laparotomy
• Enrollment: 140

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Experimental: OTL38 Injection and Near Infrared Imaging	Sham Comparator: OTL38 Injection and No Fluorescent Imaging
Arm/Group Description	Patient injected with OTL38 and undergoes near infrared imaging. Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes Other Names: OTL38 for Injection Device: near infrared camera imaging system Infrared imaging used to excite OTL38 for fluorescence Other Names: Near IR imaging Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery	Patient injected with OTL38, but does not undergo fluorescent imaging. Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes Other Names: OTL38 for Injection Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Period Title: Overall Study
Started	134	6
Safety Analysis Set [1]	134	16
Full Analysis Set/ Intent to Image Set	134	0
Per Protocol Analysis Set	106	0
Pharmacokinetic Analysis Set	122	6
Completed	128	6
Not Completed	6	0
Reason Not Completed
Lost to Follow-up	2	0
Death	1	0
Majority of which were disease too extensive and camera not used	3	0
[1] All subjects received study drug prior to randomization. A total of 150 subjects received study drug, 10 of which were not randomized to either arm. These 10 subjects withdrew to the study prior to randomization but are included in the Safety Analysis Set.

Baseline Characteristics

Arm/Group Title		Experimental: OTL38 Injection and Near Infrared Imaging	Sham Comparator: OTL38 Injection and No Fluorescent Imaging	Total
Arm/Group Description		Patient injected with OTL38 and undergoes near infrared imaging. Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes Other Names: OTL38 for Injection Device: near infrared camera imaging system Infrared imaging used to excite OTL38 for fluorescence Other Names: Near IR imaging Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery	Patient injected with OTL38, but does not undergo fluorescent imaging. Drug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes Other Names: OTL38 for Injection Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery	Total of all reporting groups
Overall Number of Baseline Participants		134	6	140
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	134 participants	6 participants	140 participants
		60.4 (10.91)	62.8 (21.77)	60.8 (11.39)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	134 participants	6 participants	140 participants
	Female	134 100.0%	6 100.0%	140 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	134 participants	6 participants	140 participants
	Hispanic or Latino	15 11.2%	2 33.3%	17 12.1%
	Not Hispanic or Latino	116 86.6%	4 66.7%	120 85.7%
	Unknown or Not Reported	3 2.2%	0 0.0%	3 2.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	134 participants	6 participants	140 participants
	American Indian or Alaska Native	4 3.0%	0 0.0%	4 2.9%
	Asian	5 3.7%	1 16.7%	6 4.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	7 5.2%	0 0.0%	7 5.0%
	White	114 85.1%	5 83.3%	119 85.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	4 3.0%	0 0.0%	4 2.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Analysis Set
Arm/Group Description:	Patients exposed to OTL38 and who were randomly assigned to undergo NIR fluorescent imaging (OTL38+imaging) and who: Were evaluated under both normal light and NIR fluorescent light imaging; Had central pathology and histology confirmation for at least one FR+ ovarian cancer lesion detected under normal light or NIR fluorescent light imaging
Overall Number of Participants Analyzed	134
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	26.9; (19.6 to 35.2)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full Analysis Set
Arm/Group Description:	Patients exposed to OTL38 and who were randomly assigned to undergo NIR fluorescent imaging (OTL38+imaging) and who: Were evaluated under both normal light and NIR fluorescent light imaging; Had central pathology and histology confirmation for at least one FR+ ovarian cancer lesion detected under normal light or NIR fluorescent light imaging
Overall Number of Participants Analyzed	134
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	20.2; (13.7 to 28.0)

Adverse Events

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).
Adverse Event Reporting Description	The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
Arm/Group Title	Safety Analysis Set
Arm/Group Description	The Safety Analysis Set includes all subjects who received any amount of study drug.
All-Cause Mortality
	Safety Analysis Set
	Affected / at Risk (%)
Total	2/150 (1.33%)
Serious Adverse Events
	Safety Analysis Set
	Affected / at Risk (%)
Total	22/150 (14.67%)
Blood and lymphatic system disorders
Anaemia * 1	1/150 (0.67%)
Cardiac disorders
Sinus tachycardia * 1	1/150 (0.67%)
Supraventricular tachycardia * 1	1/150 (0.67%)
Gastrointestinal disorders
Abdominal pain * 1	1/150 (0.67%)
Diverticular perforation * 1	1/150 (0.67%)
Gastric perforation * 1	1/150 (0.67%)
Vomiting * 1	1/150 (0.67%)
Hepatobiliary disorders
Cholelithiasis * 1	1/150 (0.67%)
Immune system disorders
Postoperative wound infection * 1	1/150 (0.67%)
Infections and infestations
Septic shock * 1	2/150 (1.33%)
Abscess * 1	1/150 (0.67%)
Clostridium difficile infection * 1	1/150 (0.67%)
Peritonitis * 1	1/150 (0.67%)
Pneumonia * 1	1/150 (0.67%)
Sepsis * 1	1/150 (0.67%)
Injury, poisoning and procedural complications
Postoperative ileus * 1	3/150 (2.00%)
Anastomotic leak * 1	1/150 (0.67%)
Post procedural haemorrhage * 1	1/150 (0.67%)
Vaginal cuff dehiscence * 1	1/150 (0.67%)
Metabolism and nutrition disorders
Hypoalbuminaemia * 1	1/150 (0.67%)
Hyponatraemia * 1	1/150 (0.67%)
Metabolic acidosis * 1	1/150 (0.67%)
Nervous system disorders
Ischaemic stroke * 1	1/150 (0.67%)
Renal and urinary disorders
Acute kidney injury * 1	3/150 (2.00%)
Renal impairment * 1	1/150 (0.67%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion * 1	2/150 (1.33%)
Acute respiratory distress syndrome * 1	1/150 (0.67%)
Acute respiratory failure * 1	1/150 (0.67%)
Hypoxia * 1	1/150 (0.67%)
Vascular disorders
Hypotension * 1	1/150 (0.67%)
Hypovolaemic shock * 1	1/150 (0.67%)
1 Term from vocabulary, MedDRA (20.1); * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Safety Analysis Set
	Affected / at Risk (%)
Total	34/150 (22.67%)
Gastrointestinal disorders
Nausea * 1	27/150 (18.00%)
Vomiting * 1	8/150 (5.33%)
Abdominal pain * 1	7/150 (4.67%)
1 Term from vocabulary, MedDRA (20.1); * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Tommy Lee, MSHS, Vice President, Clinical Operations
• Organization: On Target Laboratories
• Phone: 765-588-4547
• EMail: Tlee@ontargetlabs.com

• Responsible Party: On Target Laboratories, LLC
• ClinicalTrials.gov Identifier: NCT03180307
• Other Study ID Numbers: OTL-2016-OTL38-006
• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Results First Submitted: October 14, 2021
• Results First Posted: February 4, 2022
• Last Update Posted: February 4, 2022