Trial Outcomes & Findings for Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma (NCT NCT00473343)
NCT ID: NCT00473343
Last Updated: 2023-01-05
Results Overview
Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.
COMPLETED
PHASE3
102 participants
3 months after last Metvix PDT cycle, up to 6 months
2023-01-05
Participant Flow
A total of 102 participants were randomized at seven different center in Australia.
Participant milestones
| Measure |
Metvix® PDT
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Metvix® PDT
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Treatment failure
|
27
|
|
Overall Study
Withdrew consent
|
3
|
|
Overall Study
Other un-specified reason
|
3
|
Baseline Characteristics
Metvix PDT in Participant With "High Risk" Basal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Metvix® PDT
n=102 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Age, Continuous
|
64 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 months after last Metvix PDT cycle, up to 6 monthsPopulation: Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment.
Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination.
Outcome measures
| Measure |
Metvix® PDT
n=102 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 3 months after last Metvix PDT cycle, up to 6 monthsPopulation: Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment.
Complete response was defined as no clinically visible BCC lesions in the treatment area.
Outcome measures
| Measure |
Metvix® PDT
n=165 lesions
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle
|
141 lesions
|
SECONDARY outcome
Timeframe: 3 months after the last metvix PDT cycle, up to 6 monthsPopulation: Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as: * excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin * good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin * fair: slight to moderate occurrence of scarring, atrophy or induration * poor: extensive occurrence of scarring, atrophy or induration.
Outcome measures
| Measure |
Metvix® PDT
n=82 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle
Investigator: Excellent
|
37 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle
Investigator: Good
|
16 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle
Investigator: Fair
|
28 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle
Investigator: Not applicable
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months after the last metvix PDT cycle, up to 6 monthsPopulation: Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.
Outcome measures
| Measure |
Metvix® PDT
n=81 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle
Participants: Excellent
|
40 Participants
|
|
Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle
Participants: Good
|
39 Participants
|
|
Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle
Participants: Fair
|
2 Participants
|
|
Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle
Participants: Not applicable
|
0 Participants
|
SECONDARY outcome
Timeframe: 12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 yearsPopulation: Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. "Number analyzed", signifies those participants who were evaluable for this outcome measure at the specified time point.
Recurrence rate in complete clearance(CC) group was analyzed.
Outcome measures
| Measure |
Metvix® PDT
n=69 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Recurrence Rate in Complete Clearance Group
12 months
|
8 Participants
|
|
Recurrence Rate in Complete Clearance Group
24 months
|
16 Participants
|
|
Recurrence Rate in Complete Clearance Group
36 months
|
20 Participants
|
|
Recurrence Rate in Complete Clearance Group
48 months
|
21 Participants
|
|
Recurrence Rate in Complete Clearance Group
60 months
|
23 Participants
|
SECONDARY outcome
Timeframe: 24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 yearsPopulation: Intent-to-treat analysis set included all the participants enrolled in the study who received at least one dose of study treatment. Here overall "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. "Number analyzed", signifies those participants who were evaluable for this outcome measure at the specified time point.
Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as: excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration.
Outcome measures
| Measure |
Metvix® PDT
n=57 Participants
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Excellent: At 24 month
|
34 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Good: At 24 month
|
15 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Fair: At 24 month
|
7 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Poor: At 24 month
|
1 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Excellent: At 36 month
|
31 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Good: At 36 month
|
13 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Fair: At 36 month
|
6 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Excellent: At 60 month
|
35 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Good: At 60 month
|
7 Participants
|
|
Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
Fair: At 60 month
|
1 Participants
|
Adverse Events
Metvix® PDT
Serious adverse events
| Measure |
Metvix® PDT
n=102 participants at risk
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.98%
1/102 • Baseline up to Month 60
|
|
Skin and subcutaneous tissue disorders
Burning sensation skin
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Surgical intervention
|
0.98%
1/102 • Baseline up to Month 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.98%
1/102 • Baseline up to Month 60
|
|
Vascular disorders
Stroke
|
0.98%
1/102 • Baseline up to Month 60
|
|
Vascular disorders
Peripheral vascular disease
|
0.98%
1/102 • Baseline up to Month 60
|
|
Infections and infestations
Systemic infection
|
0.98%
1/102 • Baseline up to Month 60
|
|
Hepatobiliary disorders
Encephalopathy
|
0.98%
1/102 • Baseline up to Month 60
|
|
Gastrointestinal disorders
Peritonitis
|
0.98%
1/102 • Baseline up to Month 60
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.98%
1/102 • Baseline up to Month 60
|
Other adverse events
| Measure |
Metvix® PDT
n=102 participants at risk
Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 milliwatt per centimeter square (mW/cm\*2) up to 13 weeks.
|
|---|---|
|
General disorders
Pain
|
2.9%
3/102 • Baseline up to Month 60
|
|
General disorders
Chest pain
|
2.0%
2/102 • Baseline up to Month 60
|
|
General disorders
Influenza like symptom
|
2.0%
2/102 • Baseline up to Month 60
|
|
General disorders
Back ache
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Leg pain
|
0.98%
1/102 • Baseline up to Month 60
|
|
Cardiac disorders
Allergic reaction
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Cervical pain
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Heaviness in limbs
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Oedema peripheral
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Feeling cold
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Fatigue
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Sensation of warmth
|
0.98%
1/102 • Baseline up to Month 60
|
|
Gastrointestinal disorders
Nausea
|
3.9%
4/102 • Baseline up to Month 60
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/102 • Baseline up to Month 60
|
|
Gastrointestinal disorders
Stomach upset
|
0.98%
1/102 • Baseline up to Month 60
|
|
Gastrointestinal disorders
Dyspepsia
|
0.98%
1/102 • Baseline up to Month 60
|
|
Gastrointestinal disorders
Constipation
|
0.98%
1/102 • Baseline up to Month 60
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Baseline up to Month 60
|
|
Gastrointestinal disorders
Peritonitis
|
0.98%
1/102 • Baseline up to Month 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basel cell carcinoma
|
7.8%
8/102 • Baseline up to Month 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm malignant
|
0.98%
1/102 • Baseline up to Month 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin carcinoma
|
0.98%
1/102 • Baseline up to Month 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.98%
1/102 • Baseline up to Month 60
|
|
Nervous system disorders
Headache
|
5.9%
6/102 • Baseline up to Month 60
|
|
Nervous system disorders
Dizziness
|
0.98%
1/102 • Baseline up to Month 60
|
|
Nervous system disorders
Encephalopathy
|
0.98%
1/102 • Baseline up to Month 60
|
|
Infections and infestations
Infection
|
2.9%
3/102 • Baseline up to Month 60
|
|
Infections and infestations
Infection fungal
|
0.98%
1/102 • Baseline up to Month 60
|
|
Infections and infestations
Ear infection
|
0.98%
1/102 • Baseline up to Month 60
|
|
Immune system disorders
Herpes simplex
|
0.98%
1/102 • Baseline up to Month 60
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.98%
1/102 • Baseline up to Month 60
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.98%
1/102 • Baseline up to Month 60
|
|
Musculoskeletal and connective tissue disorders
Pain neck shoulder
|
0.98%
1/102 • Baseline up to Month 60
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.98%
1/102 • Baseline up to Month 60
|
|
Psychiatric disorders
Depression
|
0.98%
1/102 • Baseline up to Month 60
|
|
Psychiatric disorders
Mental distress
|
0.98%
1/102 • Baseline up to Month 60
|
|
Psychiatric disorders
psychosis
|
0.98%
1/102 • Baseline up to Month 60
|
|
Psychiatric disorders
Anxiety
|
0.98%
1/102 • Baseline up to Month 60
|
|
Eye disorders
Eye pain
|
2.9%
3/102 • Baseline up to Month 60
|
|
Eye disorders
conjunctivitis
|
0.98%
1/102 • Baseline up to Month 60
|
|
Vascular disorders
Stroke
|
0.98%
1/102 • Baseline up to Month 60
|
|
Vascular disorders
Skin warm
|
0.98%
1/102 • Baseline up to Month 60
|
|
Vascular disorders
Peripheral vascular disease
|
0.98%
1/102 • Baseline up to Month 60
|
|
Blood and lymphatic system disorders
Haematoma
|
0.98%
1/102 • Baseline up to Month 60
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.98%
1/102 • Baseline up to Month 60
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.98%
1/102 • Baseline up to Month 60
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.98%
1/102 • Baseline up to Month 60
|
|
Cardiac disorders
Angina pectoris
|
0.98%
1/102 • Baseline up to Month 60
|
|
Cardiac disorders
Hypertension
|
0.98%
1/102 • Baseline up to Month 60
|
|
General disorders
Application site reaction
|
0.98%
1/102 • Baseline up to Month 60
|
|
Renal and urinary disorders
Haematuria
|
0.98%
1/102 • Baseline up to Month 60
|
|
Surgical and medical procedures
Surgical intervention
|
8.8%
9/102 • Baseline up to Month 60
|
|
Surgical and medical procedures
Abrasion NOS
|
0.98%
1/102 • Baseline up to Month 60
|
|
Surgical and medical procedures
Prostatic specific antigen INCR.
|
0.98%
1/102 • Baseline up to Month 60
|
|
Cardiac disorders
Heart Failure
|
0.98%
1/102 • Baseline up to Month 60
|
|
Hepatobiliary disorders
Liver failure related to Chronic Hepatitis B infection
|
0.98%
1/102 • Baseline up to Month 60
|
|
Cardiac disorders
Cardiac arrest
|
0.98%
1/102 • Baseline up to Month 60
|
|
Vascular disorders
Cerebrovascular accident
|
0.98%
1/102 • Baseline up to Month 60
|
|
Skin and subcutaneous tissue disorders
Metastatic squamous cell carcinoma
|
0.98%
1/102 • Baseline up to Month 60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place