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NCT01364844 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of DS-7423 in Subjects With Advanced Solid Malignant Tumors
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01364844: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT01364844 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01364844, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This will be a Phase 1, open-label study of DS-7423 to assess its safety and tolerability, identify a RP2D, (recommended Phase 2 Dose) and assess its Pharmacokinetics (PK) (what your body does to process the drugs and how your body gets them out of your system.) and pharmacodynamics (PDy) (Pharmacodynamics is a study of what a drug does to your body) properties in subjects with advanced solid malignant tumors. This study will include 2 parts: part 1-Dose Escalation and part 2-Dose Expansion. Study Hypothesis: DS-7423 will be safe and tolerable, and will exhibit acceptable PK and PDy properties in subjects with advanced solid malignant tumors for whom standard therapy has failed or for whom no standard therapy exists.
Primary Outcome
All adverse events will be graded according to the NCI-CTCAE, version 4.0
Interventions
- DRUG DS-7423
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01364844 record still lists
NCT01364844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which DS-7423 is the first listed.
NCT01364844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01364844 about?
NCT01364844 is a clinical study titled "Safety and Tolerability of DS-7423 in Subjects With Advanced Solid Malignant Tumors". This will be a Phase 1, open-label study of DS-7423 to assess its safety and tolerability, identify a RP2D, (recommended Phase 2 Dose) and assess its Pharmacokinetics (PK) (what your body does to process the drugs and how your body gets them out of your system.) and pharmacodynamics (PDy) (Pharmacod...
What is the current status of trial NCT01364844?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2011-07. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01364844?
The interventions under investigation include: DS-7423 (DRUG).
Who is sponsoring clinical trial NCT01364844?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01364844's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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