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NCT03401385 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)
A Phase 1 study of Non-Small Cell Lung Cancer and Triple Negative Breast Cancer, sponsored by Daiichi Sankyo Co..
- Active
- Registry status
- Phase 1
- Development phase
- 890
- Enrollment target
- 18
- Study locations
NCT03401385: Active Phase 1 study of Non-Small Cell Lung Cancer and Triple Negative Breast Cancer, sponsored by Daiichi Sankyo Co..
NCT03401385 is a Phase 1 study of Non-Small Cell Lung Cancer and Triple Negative Breast Cancer that is active but no longer recruiting, run by Daiichi Sankyo Co.. The registered enrollment target is 890 participants, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (37% higher). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03401385, a Phase 1 study of Non-Small Cell Lung Cancer and Triple Negative Breast Cancer, is active but no longer recruiting, sponsored by Daiichi Sankyo Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 890 participants
- Enrollment target
- 18
- Study locations
Study Summary
This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study. The primary purpose of the parts are: * Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a * Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: * they withdraw * their disease gets worse * they experience unacceptable side effects. The primary purpose of the sub-study is to compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis in participants receiving DS-1062a. The sub-study is a randomized study that will include approximately 76 participants enrolling into the Dose Expansion part.
Primary Outcome
Dose-limiting toxicities are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Conditions Studied
Interventions
- DRUG Datopotamab Deruxtecan (Dato-DXd)
- DRUG Steroid Containing Mouthwash
- OTHER Non-Steroid Containing Mouthwash
Study Locations (18)
Texas
- MD Anderson Cancer Center - Houston
- Next Oncology - San Antonio
- START Oncology - San Antonio
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
New York
- Tisch Cancer Institute, Icahn School of Medicine - New York
- Memorial Sloan-Kettering Cancer Center - New York
Tokyo
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research - Koto-Ku
- Showa Medical University Hospital - Shinagawa-Ku
Other
- National Cancer Center Hospital - Chūōku
- National Cancer Center Hospital East - Kashiwa
California
- University of California, Los Angeles - Los Angeles
District of Columbia
- Johns Hopkins Sibley Memorial Hospital - Washington D.C.
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 890 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 1 |
What the registry record for NCT03401385 still lists
NCT03401385 is an interventional study that assigns participants to a tested intervention. The registered 890 participants enrollment target is mid-sized for trials with a published cap, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (37% higher).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Datopotamab Deruxtecan (Dato-DXd) is the first listed.
NCT03401385 lists 18 locations in 12 states (Texas, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT03401385 about?
NCT03401385 is a clinical study titled "First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)". This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study. The primary purpose of the parts are: * Dose Escalation: To investigat...
What is the current status of trial NCT03401385?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 890 participants. The study started on 2018-01-31. Estimated completion is 2027-01-01.
What conditions does trial NCT03401385 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Hormone Receptor-Positive Breast Cancer.
What interventions are being tested in trial NCT03401385?
The interventions under investigation include: Datopotamab Deruxtecan (Dato-DXd) (DRUG), Steroid Containing Mouthwash (DRUG), Non-Steroid Containing Mouthwash (OTHER).
Who is sponsoring clinical trial NCT03401385?
This trial is sponsored by Daiichi Sankyo Co., which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03401385 being conducted?
This trial has 18 study locations across California, District of Columbia, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03401385's enrollment target sits among peer trials
890 27th of 454 higher than 428 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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