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DS-8201a for Solid Cancers
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 1 trial • 292 Patients • NCT02564900Trial Design
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Who is running the clinical trial?
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- You have advanced breast cancer with low levels of HER2 and have either not responded to standard treatment or cannot tolerate it. There is also no other approved treatment available for your condition.You have a history of serious lung diseases.You have advanced or spreading breast cancer, stomach cancer, or cancer in the area where the stomach and esophagus meet. The cancer is not responding to standard treatments, or there are no standard treatments available.You have a type of cancer that has spread or cannot be surgically removed. It has a specific protein called HER2, and you have tried standard treatments that haven't worked or cannot be tolerated.
- Group 1: Part 1 Dose escalation
- Group 2: Part 2 Dose expansion
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA approved DS-8201a (DP) for use?
"Though there is limited data available for DS-8201a (DP), its safety was assessed with a score of 1. This evaluation reflects the fact that this treatment is currently undergoing Phase 1 clinical trials, which assesses initial efficacy and safety."
What is the aggregate figure of participants involved in this research?
"At this time, enrollment for the study is closed. The initial posting date was September 1st 2015, and it's last update occurred October 4th 2022. If looking for other studies, there are presently 2503 clinical trials targeting cancer that have open registration slots along with 36 studies regarding DS-8201a (DP)."
Are there any openings left for participants in this clinical investigation?
"This clinical trial has concluded its recruitment process. Originally posted on September 1st 2015 and last updated on October 4th 2022, it is no longer searching for participants. However, there are currently 2503 open trials recruiting patients with cancer and 36 studies that are accepting enrolments related to DS-8201a (DP)."
Is this research pioneering within its field?
"Since 2015, Daiichi Sankyo Inc. has sponsored extensive research into DS-8201a (DP). After a 292 participant initial trial in 2015, the drug was approved for Phase 1 trials and is currently being tested in 36 studies across 44 countries and 483 cities."
What other investigations have been done concerning DS-8201a (DP)?
"At this time, there are 36 ongoing clinical trials associated with DS-8201a (DP). Of those studies, 10 are in Phase 3. While many of the experiments for this treatment take place in Xi'an and New york City, across the globe there exists a total of 3277 locations that have been used to run these tests."
Is the clinical trial being conducted in numerous locales across the United States?
"Mayo Clinic in Jacksonville, Florida, University of Texas M. D. Anderson Cancer Center in Houston, Texas, and Sharp Memorial Hospital in San Diego are all recruiting patients for this trial while 8 more locations also accept participants."
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