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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 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 42 participants.
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.
Interventions
- DRUG DS-7423
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01364844
The ClinicalTrials.gov registry entry for NCT01364844 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DS-7423 is the first listed.
NCT01364844 reports 0 study locations.
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.
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