Ovarian Cancer
Conditions
Brief summary
This study is being done to: * test the safety of OTL38 * see if OTL38 helps light up the cancer when viewed with the special camera system * test the safety of the special camera system for use along with OTL38 during surgery
Interventions
DRUGOTL38
Near infrared camera imaging system
PROCEDURELaparotomy
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Sponsors
SynteractHCR
On Target Laboratories, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female patients 18 years of age and older 2. Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking 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 3. 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 4. 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 5. Ability to understand the requirements of the study, provide written informed consent 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
Exclusion criteria
1. Previous exposure to OTL38 2. Known FR alpha-negative ovarian cancer 3. Planned surgical approach via laparoscopy or robotic surgery 4. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient 5. History of anaphylactic reactions or severe allergies 6. History of allergy to any of the components of OTL38, including folic acid 7. Pregnancy, or positive pregnancy test 8. Clinically significant abnormalities on electrocardiogram (ECG) 9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 10. Impaired renal function defined as eGFR\< 50 mL/min/1.73m2 11. Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin. 12. Known Stage IV ovarian cancer with Brain Metastases 13. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery 14. Known sensitivity to fluorescent light
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery. | Day of Surgery (Day 1) | Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used. |
| Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery. | Day of Surgery (Day 1) | PPV for the detection of FRAP ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAP ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by fluorescent light (TP + FP). 95% lower one-sided confidence interval was used. |
Countries
United States
Participant flow
Pre-assignment details
Subjects were screened up to 28 days prior to surgery.
Participants by arm
| Arm | Count |
|---|---|
| OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Drug not usable | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 63.8 years STANDARD_DEVIATION 10.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 44 / 44 |
| serious Total, serious adverse events | 13 / 44 |
Outcome results
Primary
Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
PPV for the detection of FRAP ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAP ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by fluorescent light (TP + FP). 95% lower one-sided confidence interval was used.
Time frame: Day of Surgery (Day 1)
Population: Population includes all patients who received OTL38, underwent cytoreductive surgery for PPV analysis, were exposed to fluorescent light using the imaging system, and had at least one FRAP target ovarian cancer lesion. Patients enrolled to the study after adequate number of lesions have been excised and submitted for pathology, and immunohistochemistry evaluation for determining PPV, enrolled after protocol amendment 4, were not included in the analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery. | 94.93 percentage of lesions |
Primary
Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used.
Time frame: Day of Surgery (Day 1)
Population: Population includes all patients who received OTL38, underwent cytoreductive surgery for sensitivity analysis, were exposed to fluorescent light using the imaging system, and had at least one FRAP target ovarian cancer lesion. Patients enrolled to the study after adequate number of lesions have been excised and submitted for pathology, and immunohistochemistry evaluation for determining sensitivity, enrolled after protocol amendment 4, were not included in the analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery. | 97.97 percentage of lesions |