A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion

NCT03279744 | Completed Phase 2

• 1 other identifier: IRC241001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia).

Conditions

Erythroleukoplakia of Mouth; Verrucous Hyperplasia of Oral Mucosa

Keywords

Oral Verrucous Hyperplasia; Oral Erythroleukoplakia

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoints: the complete response rate is higher or equal to 70% of total

  The complete response rate at the end of treatment will be calculated by the proportion of complete response patients in total. The primary efficacy endpoints will be summarized by examining whether the complete response rate is higher or equal to 70% of total. Complete response (CR): lack of detectable lesion confirmed by visual evaluation.

  2-week safety follow-up period after last treatment

Study Arms (1)

Single-Arm

EXPERIMENTAL

Radion™-pdt

Drug: Radion™-pdt

Interventions

Radion™-pdt DRUG

The Radion™-pdt will be applied topically to the lesion. The Radion™-pdt applied dosage is about 0.1 mL/cm\^2 and properly cover the entire lesion.

Single-Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥20 years old;
• Patient with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL) lesions with histological evidence of oral precancerous lesions. Besides, patients should have at least one lesion whose size should not exceed 4 cm in the greatest diameter and the distance between two lesions should not less than 1 cm.
• Patient who is willing and able to comply with study procedures and sign informed consent

You may not qualify if:

• Patients with history of hypersensitivity to any photosensitizer (including 5-aminolevulinic acid HCl or porphyrins), acute or chronic types of porphyria;
• Record of previous unsuccessful treatment with photodynamic therapy;
• Patients who have been diagnosed as having oral cancer or carcinoma in situ;
• Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;
• Patients with impaired hepatic function (defined as AST and/or ALT \> 2× the upper limit of normal values), and/or impaired renal function (defined as serum creatinine \> 1.5 mg/dL);
• Female patient of childbearing potential who:
• is lactating; or
• has positive urine pregnancy test at visit -1; or
• refuses to adopt reliable method of contraception during the study;
• Patient has received any other investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first photodynamic therapy;
• Patient has a history of illegal substance abuse, drug addiction or alcoholism within 24 weeks prior to the study.

Sponsors & Collaborators

• Pharma Power Biotec Co., Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 100, Taiwan

Location

Study Officials

• Hsin-Ming Chen

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 12, 2017
• Study Start: September 6, 2017
• Primary Completion: September 4, 2019
• Study Completion: December 20, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

TW (1)