Active — Not RecruitingPhase 1/2

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

United States23 participantsStarted 2017-03-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 PEG Eligibility criteria will be assessed by an experienced oral surgeon, typically the Co-PI of the study.

What they're measuring

escalating levels of toxicity (CTCAE v 4.0)

Timeframe: 1 year

Trial details

NCT IDNCT03085147

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Oral Squamous Cell Carcinoma (OSCC) trials