Trials / Unknown
UnknownNCT04759664
LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Topically Administered LUT014 in Metastatic Colorectal Cancer Patients With EGFR Inhibitor Induced Acneiform Lesions
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 117 (estimated)
- Sponsor
- Lutris Pharma Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study evaluates the efficacy and safety of two strengths of LUT014 Gel topically applied once a day for 4 weeks, compared to placebo, in metastatic colorectal cancer (mCRC) patients who developed Grade 2 or non-infected Grade 3 EGFRI induced acneiform lesions
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUT014 Gel (Dose 1) | Topical gel |
| DRUG | LUT014 Gel (Dose 2) | Topical gel |
| DRUG | Placebo | LUT014 matching placebo topical gel |
Timeline
- Start date
- 2021-04-12
- Primary completion
- 2024-03-01
- Completion
- 2024-05-01
- First posted
- 2021-02-18
- Last updated
- 2023-10-06
Locations
20 sites across 2 countries: United States, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04759664. Inclusion in this directory is not an endorsement.