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PARP Inhibitor

Cancer-Detecting Dye for Oral Cancer

Phase 1 & 2
Recruiting
Led By Heiko Schoder, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0 or 1
Patient is ≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new cancer-detecting dye to see if it is safe and effective.

Who is the study for?
This trial is for adults over 18 with squamous cell carcinoma in the mouth or throat, who are scheduled for surgery and have not had recent oral surgery. They must be able to perform daily activities with little to no assistance (ECOG status 0-1) and cannot have had prior treatment with PARP inhibitors.Check my eligibility
What is being tested?
The study is testing a new dye called PARPi-FL to see if it can help detect cancer in the tongue and mouth. Participants will receive varying doses of this investigational dye to determine its safety and the optimal amount needed for cancer detection.See study design
What are the potential side effects?
Since this is the first time PARPi-FL is being used in humans, specific side effects are unknown but may include reactions related to Olaparib sensitivity such as allergic reactions, since individuals with known hypersensitivity to Olaparib are excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My cancer is a type of squamous cell carcinoma located in my mouth or throat.
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My cancer is at any stage but has not spread to distant organs.
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I am scheduled for surgery at MSK.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
escalating levels of toxicity (CTCAE v 4.0)

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
General physical health deterioration
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fluorescent PARPi Binding Imaging Agent PARPi-FLExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,248 Total Patients Enrolled
Heiko Schoder, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
676 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03085147 — Phase 1 & 2
Oral Squamous Cell Carcinoma Research Study Groups: Fluorescent PARPi Binding Imaging Agent PARPi-FL
Oral Squamous Cell Carcinoma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03085147 — Phase 1 & 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03085147 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for potential participants in this experiment?

"This clinical trial is still accepting patients; the listing was posted on March 15th 2017 and its most recent update occured June 3rd of this year."

Answered by AI

Is this clinical trial a pioneering endeavor?

"Olaparib has seen 188 active medical trials in 1468 cities and 59 nations since its Phase 1 trial by AstraZeneca began in 2005. Since then, 63 further investigations have been concluded."

Answered by AI

What medical conditions may Olaparib be utilized to address?

"Olaparib is usually prescribed for cases of advanced illness. It has also been seen to alleviate malignant neoplasm of ovary, primary peritoneal cancer, and somatic hallucinations."

Answered by AI

Are there any historical reports of Olaparib being tested in clinical trials?

"Currently, 188 medical trials are investigating olaparib. 27 of those experiments have moved on to the third stage of testing and Houston is home to the majority; though there are 9250 areas that host studies about this medication."

Answered by AI

How many participants are included in this trial's scope?

"Affirmative. According to information presented on clinicaltrials.gov, this research project is actively seeking volunteers and has been since the 15th of March 2017. Most recently updated on June 3rd 2022, it needs 39 individuals from one medical centre for participation."

Answered by AI
~9 spots leftby Jul 2026