An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Condition(s) studied
Investigational drug(s) / intervention(s)
Dexamethasone mouthwash: Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.
Datopotamab Deruxtecan (Dato-DXd): Commercially available Dato-DXd is prescribed and administered to participants according to standard of care
Study summary
This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer
Eligibility
Primary outcome measure(s)
- Incidence and severity of Dato-DXd treatment-emergent grade ≥ 2 stomatitis in patients receiving prophylactic dexamethasone mouthwash within first 12 weeks of study treatment — From date of first dose of study treatment until 12 weeks after date of first dose of study treatment
Incidence is defined as the proportion of participants who develop National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 grade ≥ 2 stomatitis accompanied by either a Normalcy of Diet Subscale score ≤ 50 and/or a Numeric Rating Scale (NRS) oral-pain score of 7 on 2 consecutive days or 8, 9, or 10 on any one day. Severity will be based on the highest NCI-CTCAE v5.0 grade of stomatitis experienced by each participant. CTCAE displays Grades 1-5 with descriptions of severity for each adverse event (AE). Grade 1 for mild symptoms and Grade 5 for death related to AE. The Normalcy of Diet Subscale assesses the degree to which a patient can eat a normal diet and drink liquids. The scale is a ranking of 10 food categories, from easy-to-eat to difficult-to-eat. The Numeric Rating Scale is a scale for self-reporting of pain. Scores range from 0-10, with higher scores meaning the worst pain possible (0=no pain to 10=worst possible pain).
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Tucson | Arizona | Withdrawn |
| Research Site | Hot Springs | Arkansas | Recruiting |
| Research Site | Little Rock | Arkansas | Recruiting |
| Research Site | Duarte | California | Not Yet Recruiting |
| Research Site | Glendale | California | Recruiting |
| Research Site | Lakewood | California | Recruiting |
| Research Site | Long Beach | California | Recruiting |
| Research Site | Torrance | California | Not Yet Recruiting |
| Research Site | Washington D.C. | District of Columbia | Withdrawn |
| Research Site | Coral Springs | Florida | Recruiting |
| Research Site | Plantation | Florida | Recruiting |
| Research Site | Athens | Georgia | Recruiting |
| Research Site | Boise | Idaho | Withdrawn |
| Research Site | Park Ridge | Illinois | Withdrawn |
| Research Site | Fort Wayne | Indiana | Recruiting |
| Research Site | Elizabethtown | Kentucky | Recruiting |
| Research Site | Lexington | Kentucky | Recruiting |
| Research Site | Lexington | Kentucky | Not Yet Recruiting |
| Research Site | Louisville | Kentucky | Recruiting |
| Research Site | New Orleans | Louisiana | Not Yet Recruiting |
| Research Site | Frederick | Maryland | Withdrawn |
| Research Site | Glenn Dale | Maryland | Not Yet Recruiting |
| Research Site | Detroit | Michigan | Not Yet Recruiting |
| Research Site | Grayling | Michigan | Recruiting |
| Research Site | Minneapolis | Minnesota | Recruiting |
| Research Site | Kansas City | Missouri | Recruiting |
| Research Site | Reno | Nevada | Withdrawn |
| Research Site | Lebanon | New Hampshire | Withdrawn |
| Research Site | East Syracuse | New York | Recruiting |
| Research Site | Westbury | New York | Not Yet Recruiting |
| Research Site | White Plains | New York | Withdrawn |
| Research Site | Greensboro | North Carolina | Not Yet Recruiting |
| Research Site | Wilson | North Carolina | Recruiting |
| Research Site | Cleveland | Ohio | Not Yet Recruiting |
| Research Site | Wynnewood | Pennsylvania | Recruiting |
| Research Site | West Columbia | South Carolina | Not Yet Recruiting |
| Research Site | Knoxville | Tennessee | Recruiting |
| Research Site | Fairfax | Virginia | Recruiting |
| Research Site | Charleston | West Virginia | Withdrawn |
| Research Site | Morgantown | West Virginia | Recruiting |
+ 1 more sites — see the full list on the official registry below.
More AstraZeneca trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07357597 on ClinicalTrials.gov ↗ ← All trials in the USA