Trial Outcomes & Findings for Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream (NCT NCT00189306)

Last Updated: 2010-08-10

Results Overview

Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

169 participants

Primary outcome timeframe

5 years

Results posted on

2010-08-10

Participant Flow

Study conducted in 18 study centers: 13 in Australia and 5 in New Zealand. The first subject entered this study on 27 March 2001; the last clinic visit was on 20 April 2007 and the last subject status determination (subject lost to follow-up) was on 27 April 2007.

There were 169 subjects enrolled at 18 study centers in Australia and New Zealand.

Participant milestones

Participant milestones
Measure	Aldara Aldara (imiquimod) cream 5%
Treatment Period STARTED	169
Treatment Period COMPLETED	164
Treatment Period NOT COMPLETED	5
Posttreatment Period STARTED	169
Posttreatment Period COMPLETED	157
Posttreatment Period NOT COMPLETED	12
Long-Term Follow-up STARTED	157
Long-Term Follow-up COMPLETED	119
Long-Term Follow-up NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Aldara Aldara (imiquimod) cream 5%
Treatment Period Withdrawal by Subject	2
Treatment Period Adverse Event	2
Treatment Period Protocol Violation	1
Posttreatment Period Death	1
Posttreatment Period Withdrawal by Subject	2
Posttreatment Period Noncompliance	1
Posttreatment Period Target lesion excised	1
Posttreatment Period Protocol Violation	1
Posttreatment Period Evidence of Superficial Basal Cell Ca	5
Posttreatment Period Local skin reaction/sign	1
Long-Term Follow-up Adverse Event	2
Long-Term Follow-up Death	4
Long-Term Follow-up Withdrawal by Subject	1
Long-Term Follow-up Intercurrent disease	2
Long-Term Follow-up Lost to Follow-up	9
Long-Term Follow-up Evidence of Superficial Basal Cell Ca	20

Baseline Characteristics

Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aldara n=169 Participants Aldara (imiquimod) cream 5%
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	130 Participants n=5 Participants
Age, Categorical >=65 years	39 Participants n=5 Participants
Age Continuous	57 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants
Region of Enrollment Australia	123 participants n=5 Participants
Region of Enrollment New Zealand	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: 2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required

Outcome measures

Outcome measures
Measure	Aldara n=157 Participants Aldara (imiquimod) cream 5%
Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)	119 participants

SECONDARY outcome

Timeframe: 12 week posttreatment visit

Population: Two data sets were analyzed: intent-to-treat (ITT), consisting of all enrolled subjects and per-protocol (PP), consisting of ITT subjects who were free from major protocol violations, and who applied at least 60% of the doses required by the dosing regimen.

Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)

Outcome measures

Outcome measures
Measure	Aldara n=169 Participants Aldara (imiquimod) cream 5%
Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks	159 participants

Adverse Events

Aldara

Serious events: 23 serious events

Other events: 130 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aldara n=169 participants at risk Aldara (imiquimod) cream 5%
Vascular disorders Embolism pulmonary	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkins lymphoma	1.2% 2/169 • Number of events 2 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Excision BCC R forehead	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pulmonary carcinoma	1.2% 2/169 • Number of events 2 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Surgical and medical procedures Bleeding post colonoscopy	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Vascular disorders Transient ischaemic attack	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Cardiac disorders Myocardial infarction	2.4% 4/169 • Number of events 4 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Hepatobiliary disorders Cholecyctitis	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon carcinoma	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
General disorders Carpal tunnel syndrome	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Musculoskeletal and connective tissue disorders Pathological fracture	1.8% 3/169 • Number of events 4 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Endocrine disorders Goitre	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder carcinoma	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Reproductive system and breast disorders Prostatic disorder	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Renal and urinary disorders Acute renal failure	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Cardiac disorders Supraventricular tachycardia	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Skin and subcutaneous tissue disorders Cellulitis	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Cardiac disorders Cardiac failure	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Cardiac disorders Cardiac arrest	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Cardiac disorders Myocardial ischemia	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
General disorders Chest pain	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Gastrointestinal disorders Intestinal obstruction	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Renal and urinary disorders Chronic renal failure	0.59% 1/169 • Number of events 1 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).

Other adverse events

Other adverse events
Measure	Aldara n=169 participants at risk Aldara (imiquimod) cream 5%
Skin and subcutaneous tissue disorders Application site reaction	59.2% 100/169 • Number of events 100 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Nervous system disorders Headache	13.6% 23/169 • Number of events 23 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
General disorders Pain	5.3% 9/169 • Number of events 9 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
Respiratory, thoracic and mediastinal disorders Rhinitis	4.7% 8/169 • Number of events 8 • Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).

Additional Information

Medical Director

Graceway Pharmaceuticals

Phone: 267-984-0400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place