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NCT04509596 · ClinicalTrials.gov registry record · Phase 1
DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer
A Phase 1 study of Breast Cancer Metastatic, sponsored by Dizal Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 3
- Study locations
NCT04509596: Completed Phase 1 study of Breast Cancer Metastatic, sponsored by Dizal Pharmaceuticals.
NCT04509596 is a Phase 1 study of Breast Cancer Metastatic that has completed, run by Dizal Pharmaceuticals. The registered enrollment target is 23 participants, below the 91-participant average among 17 other Breast Cancer Metastatic trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04509596, a Phase 1 study of Breast Cancer Metastatic, has completed, sponsored by Dizal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 3
- Study locations
Study Summary
DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy and in combination with trastuzumab and/or capecitabine, or in combination with T-DM1
Primary Outcome
To investigate the safety and tolerability of DZD1516
Conditions Studied
Interventions
- DRUG DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C
Study Locations (3)
Other
- Zhejiang Cancer Hospital - Hangzhou
- Cancer Hospital, Fudan University - Shanghai
California
- UCLA Hematology/Oncology Parkside - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2022-07-07 |
| Phase | Phase 1 |
What the finished NCT04509596 record still lists
NCT04509596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 91-participant average among 17 other Breast Cancer Metastatic trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Breast Cancer Metastatic appearing as the primary indexed condition, and to 1 intervention - of which DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C is the first listed.
NCT04509596 reports a single indexed study location in Other, California.
Frequently Asked Questions
What is clinical trial NCT04509596 about?
NCT04509596 is a clinical study titled "DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer". DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who have progressed following prior therapy. This is the first time this dru...
What is the current status of trial NCT04509596?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-09-21. Estimated completion is 2022-07-07.
What conditions does trial NCT04509596 study?
This clinical trial studies the following conditions: Breast Cancer Metastatic.
What interventions are being tested in trial NCT04509596?
The interventions under investigation include: DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C (DRUG).
Who is sponsoring clinical trial NCT04509596?
This trial is sponsored by Dizal Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04509596 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04509596's enrollment target sits among peer trials
23 17th of 17 higher than 1 of 17 other Breast Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Metastatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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