WithdrawnPhase 1/2

Study to Evaluate the Safety of ATR-04

Stopped: Business reasons.

0Started 2024-01

Plain-language summary

This is a multicenter, randomized, double-blind, placebo-controlled phase 1b/2a study designed to evaluate the safety of an investigational product called ATR-04, to reduce the severity of epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular rash on the face. This study will be performed at 10-12 clinical sites, with potentially a virtual component. Approximately 60 eligible subjects will participate. A subject's participation in the study will be up to a maximum of 86 days (up to 28 days for Screening, 28 days of BID treatment, and a 30 day no treatment follow-up period). The primary objective of this study is to evaluate the safety and tolerability of ATR-04 compared to placebo.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject must be at least 18 years of age inclusive, at the time of signing the informed consent * Subjects with a current diagnosis of cancer * IGA grade of 0 on the face * Life expectancy, in the Investigator's opinion, greater than 12 weeks * Plan to initiate treatment with one of the following EGFRI drugs (other treatments may be considered after consultation with the Sponsor): Cetuximab or Panitumumab or erlotinib * Able to use Dove sensitive skin body wash for the duration of the treatment period. * Acceptable and willing to delay start of EGFRI therapy until study eligibility is determined * Anticipated to continue EGFRI therapy for at least 28 days after the first application of study medication * Male and/or female * Contraceptive use by men or women consistent with the EGFRI treatment package insert regarding the methods of contraception for those participating in clinical studies * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol. Exclusion Criteria: * Active bacterial skin infections on the face * Inter-current illness that in the Investigator's opinion puts the subject at undue risk by study participation or interfere with the study conduct or evaluations * Pregnant women * EGFRI therapy within the previous 12 weeks * Radiation therapy exposure to the face within the previous 8 weeks * Use of topical steroids on the…

What they're measuring

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), incidence of abnormal laboratory values, abnormal physical exams and abnormal vital signs.

Timeframe: Through study completion, on average of 1 year

Trial details

NCT IDNCT04731259

SponsorAzitra Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01