Overview

A Dye for the Detection of Cancer of the Tongue and Mouth

Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Treatments:
Olaparib
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks

- Prior or ongoing treatment with a PARP1 inhibitor

- Known hypersensitivity to Olaparib

- Known hypersensitivity to PEG300 Eligibility criteria will be assessed by an
experienced oral surgeon, typically the Co-PI of the study.