Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Micronutrients

Hematinics

All Drugs and Chemicals

Vitamins

Folic Acid

Vitamin B Complex

Folinic Acid

Folate

Vitamin B9

Patient injected with OTL38, but does not undergo fluorescent imaging

Patient injected with OTL38 and undergoes near infrared imaging

0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes

OTL38

Infrared imaging used to excite OTL38 for fluorescence

near infrared camera imaging system

primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

laparotomy

Janos Tanyi, MD

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.

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

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

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

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)

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)

SynteractHCR

On Target Laboratories, LLC

The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.

The Safety Analysis Set includes all subjects who received any amount of study drug.

Safety Analysis Set

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

Experimental: OTL38 Injection and Near Infrared 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

Sham Comparator: OTL38 Injection and No Fluorescent Imaging

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Tommy Lee, MSHS, Vice President, Clinical Operations

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

Full Analysis Set

Efficacy Patient Level

Patient False Positive Rate

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

Spots Global Cancer Trial Database for OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial