A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas

Who is this study for? Patients with Oral Squamous Cell Carcinoma
What treatments are being studied? Olaparib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patient is ≥ 18 years old

• Histologically or cytologically proven squamous cell carcinoma of the oral cavity or pharynx (OSCC)

• Scheduled to undergo surgery at MSK

• Any tumor stage, any N, M0

• ECOG performance status 0 or 1

Locations
United States
New York
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Contact Information
Primary
Heiko Schoder, MD
schoderh@mskcc.org
212-639-2079
Backup
Ravinder Greawl, MD
212-639-2872
Time Frame
Start Date: March 15, 2017
Estimated Completion Date: July 2023
Participants
Target number of participants: 39
Treatments
Experimental: Fluorescent PARPi Binding Imaging Agent PARPi-FL
In the phase I of the study, increasing concentrations of PARPi-FL will be used in up to 12 patients with OSCC to determine concentration that results in the highest contrast between tumor and normal mucosa. Dose escalation will be performed in groups of three patients until image contrast decreases, side effects are noted or the concentration of PARPi-FL exceeds 1μM. Imaging will be performed in the Department of Surgery during a presurgical visit including clinical examination of the oral cavity. In the phase II part of the study the concentration of PARPi-FL determined in phase I will be used to image 18 patients with OSCC on the day of surgery. Imaging findings will be correlated with histopathologic findings in the surgically resected specimens.
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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