Trial Outcomes & Findings for OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer (NCT NCT03180307)
NCT ID: NCT03180307
Last Updated: 2022-02-04
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
30 days
Results posted on
2022-02-04
Participant Flow
Participant milestones
| Measure |
Experimental: OTL38 Injection and Near Infrared Imaging
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
|
Sham Comparator: OTL38 Injection and No Fluorescent Imaging
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
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
6
|
|
Overall Study
Safety Analysis Set
|
134
|
16
|
|
Overall Study
Full Analysis Set/ Intent to Image Set
|
134
|
0
|
|
Overall Study
Per Protocol Analysis Set
|
106
|
0
|
|
Overall Study
Pharmacokinetic Analysis Set
|
122
|
6
|
|
Overall Study
COMPLETED
|
128
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Experimental: OTL38 Injection and Near Infrared Imaging
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
|
Sham Comparator: OTL38 Injection and No Fluorescent Imaging
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Majority of which were disease too extensive and camera not used
|
3
|
0
|
Baseline Characteristics
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Experimental: OTL38 Injection and Near Infrared Imaging
n=134 Participants
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
|
Sham Comparator: OTL38 Injection and No Fluorescent Imaging
n=6 Participants
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
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 10.91 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 21.77 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPercentage 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)
Outcome measures
| Measure |
Full Analysis Set
n=134 Participants
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
|
|---|---|
|
Efficacy Patient Level
|
26.9 percentage of participants
Interval 19.6 to 35.2
|
SECONDARY outcome
Timeframe: 30 daysFalse 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)
Outcome measures
| Measure |
Full Analysis Set
n=134 Participants
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
|
|---|---|
|
Patient False Positive Rate
|
20.2 percentage of participants
Interval 13.7 to 28.0
|
Adverse Events
Safety Analysis Set
Serious events: 22 serious events
Other events: 34 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Safety Analysis Set
n=150 participants at risk
The Safety Analysis Set includes all subjects who received any amount of study drug.
|
|---|---|
|
Infections and infestations
Septic shock
|
1.3%
2/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Infections and infestations
Abscess
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Infections and infestations
Clostridium difficile infection
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Infections and infestations
Peritonitis
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Infections and infestations
Pneumonia
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Immune system disorders
Postoperative wound infection
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Infections and infestations
Sepsis
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
2.0%
3/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Injury, poisoning and procedural complications
Vaginal cuff dehiscence
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
2/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
3/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Renal and urinary disorders
Renal impairment
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Cardiac disorders
Sinus tachycardia
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Vascular disorders
Hypotension
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Vascular disorders
Hypovolaemic shock
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Nervous system disorders
Ischaemic stroke
|
0.67%
1/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
Other adverse events
| Measure |
Safety Analysis Set
n=150 participants at risk
The Safety Analysis Set includes all subjects who received any amount of study drug.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
18.0%
27/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
8/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
7/150 • Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
|
Additional Information
Tommy Lee, MSHS, Vice President, Clinical Operations
On Target Laboratories
Phone: 765-588-4547
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place