DWP708 for Treating Epidermal Growth Factor Receptor Inhibitor Related Skin Toxicities

NCT ID: NCT05378360

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2023-12-28

Brief Summary

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A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DWP708 for Treating Rash Acneiform

Detailed Description

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All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 5.0

Conditions

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Rash Acneiform

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo of DWP708

EGF Cream Placebo evenly apply to skin lesion every 12 hr/day

Group Type PLACEBO_COMPARATOR

DWP708

Intervention Type BIOLOGICAL

Placebo Comparator: Placebo of DWP708 / BID / up to 28 days Experimental: DWP708 10 ug/g / BID / up to 28 days Experimental: DWP708 20 ug/g / BID / up to 28 days Experimental: DWP708 40 ug/g / BID / up to 28 days

DWP708 10 ug/g

EGF Cream 10 ug/g evenly apply to skin lesion every 12 hr/day

Group Type EXPERIMENTAL

DWP708

Intervention Type BIOLOGICAL

Placebo Comparator: Placebo of DWP708 / BID / up to 28 days Experimental: DWP708 10 ug/g / BID / up to 28 days Experimental: DWP708 20 ug/g / BID / up to 28 days Experimental: DWP708 40 ug/g / BID / up to 28 days

DWP708 20 ug/g

EGF Cream 20 ug/g evenly apply to skin lesion every 12 hr/day

Group Type EXPERIMENTAL

DWP708

Intervention Type BIOLOGICAL

Placebo Comparator: Placebo of DWP708 / BID / up to 28 days Experimental: DWP708 10 ug/g / BID / up to 28 days Experimental: DWP708 20 ug/g / BID / up to 28 days Experimental: DWP708 40 ug/g / BID / up to 28 days

DWP708 40 ug/g

EGF Cream 40 ug/g evenly apply to skin lesion every 12 hr/day

Group Type EXPERIMENTAL

DWP708

Intervention Type BIOLOGICAL

Placebo Comparator: Placebo of DWP708 / BID / up to 28 days Experimental: DWP708 10 ug/g / BID / up to 28 days Experimental: DWP708 20 ug/g / BID / up to 28 days Experimental: DWP708 40 ug/g / BID / up to 28 days

Interventions

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DWP708

Placebo Comparator: Placebo of DWP708 / BID / up to 28 days Experimental: DWP708 10 ug/g / BID / up to 28 days Experimental: DWP708 20 ug/g / BID / up to 28 days Experimental: DWP708 40 ug/g / BID / up to 28 days

Intervention Type BIOLOGICAL

Other Intervention Names

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EGF cream

Eligibility Criteria

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Inclusion Criteria

1. Age: older than 19
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
3. Patients who have Rash acneiform Gr≥2 (NCI CTCAE v5.0)
4. Patients who are currently administering EGFR TKI or EGFR mAb

Exclusion Criteria

1. Known allergies, hypersensitivity, or intolerance to study drugs, chemotherapy drugs using this clinical trial
2. Patients with a history of topical medication

* Steroids within 3 days prior to baseline visit
* Antihistamine, Antipruritic agents, Antibiotics agents within 1 week prior to baseline visit
* Tacrolimus, Pimecrolimus within 2 weeks prior to baseline visit
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sung Yong Oh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dong-A University Hospital

Locations

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Dong-A University Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWP708201

Identifier Type: -

Identifier Source: org_study_id

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