Trial Outcomes & Findings for Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC) (NCT NCT03875859)

Last Updated: 2021-05-20

Results Overview

Overall response (OR) will be assessed in squamous cell carcinoma (SCC). Objective response (OR) will defined as the number of lesions with either a complete response (CR) or a partial response (PR) among all eligible and treated lesions, any time within 10 weeks. * Complete Response (CR) = Disappearance of target lesion * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesion * Overall Response (OR) = CR + PR

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

10 weeks

Results posted on

2021-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Remetinostat Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily. Remetinostat: Topical 1% remetinostat gel
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remetinostat n=4 Participants Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily. Remetinostat: Topical 1% remetinostat gel
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Age, Continuous	71.5 years STANDARD_DEVIATION 6.47 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	4 participants n=99 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: All treated lesions for all participants were included in the analysis.

Outcome measures

Outcome measures
Measure	Remetinostat n=4 Participants Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily. Remetinostat: Topical 1% remetinostat gel
Overall Response (OR) CR	5 tumor lesions
Overall Response (OR) PR	0 tumor lesions
Overall Response (OR) OR	5 tumor lesions

SECONDARY outcome

Timeframe: 8 weeks

Adverse events (AEs) contributing to treatment discontinuation or interruption are reported as the number of such events, a number without dispersion.

Outcome measures

Outcome measures
Measure	Remetinostat n=4 Participants Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily. Remetinostat: Topical 1% remetinostat gel
Adverse Events Contributing to Treatment Discontinuation or Interruption	1 adverse events

SECONDARY outcome

Timeframe: 8 weeks

The number of participants who discontinued treatment or experienced treatment interruption within the first 8 weeks of treatment are reported as the number of such participants, a number without dispersion.

Outcome measures

Outcome measures
Measure	Remetinostat n=4 Participants Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily. Remetinostat: Topical 1% remetinostat gel
Participants Who Discontinued Treatment or Had Treatment Interruption	1 Participants

Adverse Events

Remetinostat

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Remetinostat n=4 participants at risk Subjects will apply remetinostat gel 1% to at least 1 SCC: Topical remetinostat gel 1% applied 3 times daily. Remetinostat: Topical 1% remetinostat gel
Skin and subcutaneous tissue disorders Eczema	100.0% 4/4 • Number of events 4 • 12 weeks

Additional Information

Kavita Yang Sarin

Stanford University

Phone: 650-804-2899

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place