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

Primary Purpose

Erythroleukoplakia of Mouth, Verrucous Hyperplasia of Oral Mucosa

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Radion™-pdt

About this trial

This is an interventional treatment trial for Erythroleukoplakia of Mouth focused on measuring Oral Verrucous Hyperplasia, Oral Erythroleukoplakia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-Arm

Arm Description

Radion™-pdt

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03279744

First Posted

September 8, 2017

Last Updated

December 30, 2019

Sponsor

Pharma Power Biotec Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03279744

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

September 6, 2017 (Actual)

Primary Completion Date

September 4, 2019 (Actual)

Study Completion Date

December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharma Power Biotec Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

Detailed Description

This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL). Total duration of the study will be up to 40 weeks (from screening throughout study until completion) as follows: Screening (within 2 weeks before dosing) Treatment period (up to 14 weeks) Safety follow-up period (within 2 weeks after final treatment) Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks respectively) All enrolled patients will receive up to 8 treatments (once every two weeks) during a maximum of 14-week study treatment period. The treated lesion will be clinically evaluated and documented (clinical photograph) at each treatment visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erythroleukoplakia of Mouth, Verrucous Hyperplasia of Oral Mucosa

Keywords

Oral Verrucous Hyperplasia, Oral Erythroleukoplakia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-Arm

Arm Type

Experimental

Arm Description

Radion™-pdt

Intervention Type

Drug

Intervention Name(s)

Radion™-pdt

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2-week safety follow-up period after last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hsin-Ming Chen

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

State/Province

Zhongzheng Dist

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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