NCT04989816CompletedPhase 2
Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens
A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06)
Source: ClinicalTrials.gov · Last updated 21 Nov 2024
Brief summary (registry, in English)
This is a Phase II, open-label, single-arm, multicentre, study in China assessing the efficacy and safety of T-DXd in participants with HER2-expressing advanced gastric or GEJ adenocarcinoma who have received at least 2 prior regimens including a fluoropyrimidine agent and a platinum agent
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- First submitted
- 14 Jul 2021
- Start date
- 20 Aug 2021
- Primary completion date
- 16 Jun 2023
- Lead sponsor
- AstraZeneca
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04989816
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 95
- From 20 Aug 2021 to the primary completion date, 16 Jun 2023
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids
Other illness
- Active primary immunodeficiency, known HIV, active HBV, HCV infection.
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant severe illnesses.
Other
- Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART.
Who the study is looking for
- Male or female ≥ 18 years of age
- Pathologically documented gastric or GEJ adenocarcinoma
- Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease
- ECOG PS 0-1
- Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status
- LVEF ≥ 50%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.