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

Phase 1

Active, not recruiting

• Conditions: Oral Squamous Cell Carcinoma (OSCC)
• Interventions: Drug: Olaparib

• Registration Number: NCT03085147
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorescent PARPi Binding Imaging Agent PARPi-FL	Olaparib	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.

Primary Outcome Measures

Name	Time	Method
escalating levels of toxicity (CTCAE v 4.0)	1 year	toxicity data relevant to study interventions (CTCAE v 4.0)

Trial Locations

Locations (7)

Memorial Sloan Kettering Monmouth (Consent only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Consent Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Westchester (Consent Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Consent only); 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Bergen (Consent only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Consent only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States