PhIIa Dose-rangingSafetyTolerab Topical HT-001 Tx Skin Toxicities w/EpidermalGrowthFactorRecep Inhib
Study Description
This is a randomized, double-blind, placebo-controlled, multi-center
Phase 2a dose-ranging study to evaluate the efficacy, safety, and
tolerability of HT-001 for the treatment of EGFRI-induced skin
toxicity. The study will include adult patients (18 years of age)
receiving initial or repeat EGFRI therapy.
The study will be conducted in parallel in 2 cohorts: Part 1 (only at
selected PK sites), an open-label cohort consisting of 12 patients to
measure PK of HT-001 (2% aprepitant); and Part 2 (all sites), a
randomized, parallel arm study comparing 3 dose strengths of
HT-001 (0.5%, 1%, or 2% aprepitant) to placebo (HT-001 vehicle).
Patients in the randomized cohorts will be randomly assigned to 1 of
the 4 treatment arms in a 2:2:2:1 ratio
All patients in both open-label and blinded cohorts will apply the
study drug once a day to each area affected with cutaneous toxicity
up to 30% body surface area (BSA) involvement, inclusive of skin,
scalp, and nails.
Patients initiating EGFRI therapy will be monitored by their
oncologist for development of cutaneous toxicities and will be
referred for Screening/Baseline (V1), at which point they will be
enrolled in either the open-label cohort (Part 1) for application of
HT-001 (2% aprepitant) for 6 weeks or randomized to HT-001
(0.5%, 1.0%, or 2.0% aprepitant) or placebo (HT-001 vehicle) for
6 weeks (Part 2). Patients in the randomized, double-blind cohort
(Part 2 only) will be stratified across severity scores of acneiform
rash to allow for subgroup analysis for safety and efficacy per
severity. All affected BSA with EGFRI-related cutaneous toxicity
disorders will be treated. Patients from each arm will be monitored
for treatment failures requiring rescue medication. BSA for each
patient will be recorded at each visit and when dosing areas change,
as well as total dose applied, and any changes to application area will
be monitored.
Eligibility
- Adult patient (18 years of age at Screening/Baseline)
prescribed an approved EGFRI to treat cancer (indication within
the approved labeling for the EGFRI).
- Patient has developed a rash or symptoms of a rash (papular
and/or pustular eruptions) or symptoms of a rash (cutaneous
burning), as assessed by both Common Terminology Criteria for
Adverse Events (CTCAE) grading and ARIGA scales 3) with overall involvement 30% BSA.
- Eastern Cooperative Oncology Group (ECOG) performance
status of 0 to 2.
- Predicted life expectancy 3 months.
- Patient is able and willing to comply with contraceptive
requirements.
- Patient must have the ability and willingness to attend the
necessary visits (telehealth and in person).
- Patient must be willing and able to provide written informed
consent after the nature of the study has been explained and prior
to the commencement of any study procedures.
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.