Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy

A Randomized, Double-blind, Placebo-controlled Trial of AC-701 for Treatment of Skin Rash in Subjects With EGFR Inhibitor Therapy

Epidermal growth factor receptor inhibitor (EGFRI) therapy for cancer is associated with potentially severe face and trunk skin acneiform rash. Severe or persistent side effects may lead to decreased dose, interruption or discontinuation of EGFRI treatment. Inflammation is believed to play an important role in EGFRI-induced skin toxicity as a number of proinflammatory cytokines induced by EGFRI are released from epidermal cells, resulting in activation and recruitment of immune cells such as neutrophils and lymphocytes, and subsequent development of skin reaction associated with keratinocyte apoptosis. AC-701 has been reported its antibiotic and anti-inflammatory activities in literature, and further demonstrated in vitro effect to prevent the secretion of inflammatory cytokines associated with EGFR inhibition. This study is to evaluate the prophylactic efficacy of topical AC-701 in subjects with skin rash associated with EGFRI therapy.

Study Overview

• Status: Completed
• Conditions: EGFR Inhibitor-Induced Skin Rash
• Intervention / Treatment: Drug: AC-701 Topical Gel 0.3%; Other: Placebo Gel

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is between 20 and 80 years of age, inclusive.
2. Patients who are within ±3 days of initiating EGFR inhibitor therapy using afatinib or erlotinib, and have no prior history of using afatinib or erlotinib within 6 months.
3. Has a life expectancy of at least three months.

Exclusion Criteria:

1. Has any active dermatological conditions of the face that may interfere with the diagnosis, assessment, or treatment of face skin rash associated with targeted cancer therapy.
2. Has been treated with steroids (systemic or topical on face) to the face within 7 days prior to Day 1.
3. Patients who have been treated with oral antibiotics that known to exert anti-inflammatory effect (such as doxycycline or minocycline) within 7 days prior to Day 1.
4. Is currently treated with target therapy other than afatinib or erlotinib.
5. Receive prior treatment with any investigational product within 28 days prior to Day 1.
6. Has hypersensitivity or allergy to the study medication.
7. Has any other significant diseases, conditions, or laboratory values which, in the opinion of the investigator, might make participation not in the subject's best interest or confound the interpretation of study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AC-701; AC-701 Topical Gel 0.3%	Drug: AC-701 Topical Gel 0.3%; AC-701 Topical Gel 0.3%, BID; Other Names: AC-701
Placebo Comparator: Placebo; Placebo Gel	Other: Placebo Gel; Placebo Gel, BID; Other Names: Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with MESTT Grade 0 or 1	Week 4

Collaborators and Investigators

• Sponsor: TWi Biotechnology, Inc.
• Investigators: Study Director: Emily Lin, TWi Biotechnology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Actual): May 12, 2021
• Study Completion (Actual): May 26, 2021

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 21, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Exanthema
• Other Study ID Numbers: AC-701-ONC-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No