Trial Outcomes & Findings for Study of SOR007 Ointment for Actinic Keratosis (NCT NCT03083470)

Last Updated: 2019-05-15

Results Overview

Treatment emergent adverse events including all reported adverse events, laboratory assessments, physical examination findings, and vital signs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

56 days

Results posted on

2019-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	SOR007 0.15% SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 0.3% SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 1.0% SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 2.0% SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Ointment Vehicle SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Overall Study STARTED	6	6	6	6	9
Overall Study COMPLETED	6	6	6	6	7
Overall Study NOT COMPLETED	0	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SOR007 0.15% SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 0.3% SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 1.0% SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 2.0% SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Ointment Vehicle SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Overall Study Lost to Follow-up	0	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	0	1

Baseline Characteristics

Study of SOR007 Ointment for Actinic Keratosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SOR007 0.15% n=6 Participants SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 0.3% n=6 Participants SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 1.0% n=6 Participants SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 2.0% n=6 Participants SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Ointment Vehicle n=9 Participants SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Total n=33 Participants Total of all reporting groups
Age, Continuous	68.2 years STANDARD_DEVIATION 6.24 • n=39 Participants	67.5 years STANDARD_DEVIATION 8.07 • n=41 Participants	62.3 years STANDARD_DEVIATION 7.31 • n=35 Participants	62.2 years STANDARD_DEVIATION 11.84 • n=31 Participants	62.6 years STANDARD_DEVIATION 7.65 • n=146 Participants	64.4 years STANDARD_DEVIATION 8.26 • n=19 Participants
Sex: Female, Male Female	4 Participants n=39 Participants	1 Participants n=41 Participants	4 Participants n=35 Participants	5 Participants n=31 Participants	6 Participants n=146 Participants	20 Participants n=19 Participants
Sex: Female, Male Male	2 Participants n=39 Participants	5 Participants n=41 Participants	2 Participants n=35 Participants	1 Participants n=31 Participants	3 Participants n=146 Participants	13 Participants n=19 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants	0 Participants n=41 Participants	2 Participants n=35 Participants	0 Participants n=31 Participants	2 Participants n=146 Participants	4 Participants n=19 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=39 Participants	6 Participants n=41 Participants	4 Participants n=35 Participants	6 Participants n=31 Participants	7 Participants n=146 Participants	29 Participants n=19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) White	6 Participants n=39 Participants	6 Participants n=41 Participants	6 Participants n=35 Participants	6 Participants n=31 Participants	9 Participants n=146 Participants	33 Participants n=19 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Region of Enrollment United States	6 participants n=39 Participants	6 participants n=41 Participants	6 participants n=35 Participants	6 participants n=31 Participants	9 participants n=146 Participants	33 participants n=19 Participants

PRIMARY outcome

Timeframe: 56 days

Treatment emergent adverse events including all reported adverse events, laboratory assessments, physical examination findings, and vital signs.

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=6 Participants SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 0.3% n=6 Participants SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 1.0% n=6 Participants SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 2.0% n=6 Participants SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Ointment Vehicle n=9 Participants SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Number of Participants With Treatment Emergent Adverse Events	2 Participants	1 Participants	3 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application.

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=6 Participants SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 0.3% n=6 Participants SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 1.0% n=6 Participants SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 2.0% n=6 Participants SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Ointment Vehicle n=9 Participants SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of SOR007	NA pg·hr/mL Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	NA pg·hr/mL Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	NA pg·hr/mL Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	180 pg·hr/mL Standard Deviation 45.0	NA pg·hr/mL Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=6 Participants SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 0.3% n=6 Participants SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 1.0% n=6 Participants SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 2.0% n=6 Participants SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Ointment Vehicle n=9 Participants SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Pharmacokinetics: Peak Plasma Concentration (Cmax) of SOR007	NA pg/mL Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	NA pg/mL Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	NA pg/mL Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	18.3 pg/mL Standard Deviation 3.61	NA pg/mL Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.

SECONDARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=6 Participants SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 0.3% n=6 Participants SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 1.0% n=6 Participants SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 2.0% n=6 Participants SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Ointment Vehicle n=9 Participants SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Pharmacokinetics: Time at Which Peak Plasma Concentration is Observed (Tmax) of SOR007	NA hr Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	NA hr Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	NA hr Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.	1.33 hr Standard Deviation 2.31	NA hr Standard Deviation NA Plasma paclitaxel concentrations were generally near the limit of quantitation (10 pg/mL). Paclitaxel pharmacokinetic parameters could only be determined on Day 28 in three of the six patients treated with 2% SOR007 Ointment.

SECONDARY outcome

Timeframe: Baseline and 56 days

Population: Two subjects, both receiving Vehicle, were withdrawn early from the study; one of these subjects participated long enough to be included in the analysis of the efficacy endpoint and one did not. Therefore, there are 8 subjects in the Ointment Vehicle arm of the study.

AK lesions in the target test field were photographed and tracings were created at baseline and at subsequent visits to track whether lesions were clear or still present.

Outcome measures

Outcome measures
Measure	SOR007 0.15% n=6 Participants SOR007 Ointment 0.15% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 0.3% n=6 Participants SOR007 Ointment 0.3% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 1.0% n=6 Participants SOR007 Ointment 1.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	SOR007 2.0% n=6 Participants SOR007 Ointment 2.0% was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.	Ointment Vehicle n=8 Participants SOR007 Ointment vehicle was applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolved. The maximum total amount of SOR007 applied daily was 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, was treated.
Percent Change in Number of AK Lesions	-34.68 Percent Change Standard Deviation 27.432	-34.72 Percent Change Standard Deviation 27.576	-53.06 Percent Change Standard Deviation 18.868	-58.33 Percent Change Standard Deviation 30.277	-48.75 Percent Change Standard Deviation 22.321

SECONDARY outcome

Timeframe: Baseline and 56 days

Percent change in size of AK lesions was determined with measurements obtained at Baseline and 56 days. A measurement was also obtained at Day 28, but was not used to calculated percent change for the purposes of this outcome measure.