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NCT01288430 · ClinicalTrials.gov registry record · Phase 1
A Study of DS-2248 in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Daiichi Sankyo.
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01288430: Clinical Trial Phase 1 study, sponsored by Daiichi Sankyo.
NCT01288430 is a Phase 1 study that was terminated before completion, run by Daiichi Sankyo. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01288430, a Phase 1 study, was terminated before completion, sponsored by Daiichi Sankyo.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This phase 1 clinical trial is intended to understand the safety and tolerability of a new anticancer drug in subjects with advanced solid tumors. The patients who qualify for the study will receive a once daily dose of the drug taken by mouth and will undergo several tests to measure the drug in the blood and to understand the safety, tolerability and any effect of the drug on the tumor. The antitumor effect of the drug is not known in human.
Primary Outcome
Objective response rate was defined as the sum of complete response (CR) and partial response (PR) rates. CR was defined as a disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Interventions
- DRUG DS-2248
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-03-29 |
| Est. Completion | 2014-02-13 |
| Phase | Phase 1 |
Why NCT01288430 stopped before completion
NCT01288430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which DS-2248 is the first listed.
NCT01288430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01288430 about?
NCT01288430 is a clinical study titled "A Study of DS-2248 in Participants With Advanced Solid Tumors". This phase 1 clinical trial is intended to understand the safety and tolerability of a new anticancer drug in subjects with advanced solid tumors. The patients who qualify for the study will receive a once daily dose of the drug taken by mouth and will undergo several tests to measure the drug in th...
What is the current status of trial NCT01288430?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-03-29. Estimated completion is 2014-02-13.
What interventions are being tested in trial NCT01288430?
The interventions under investigation include: DS-2248 (DRUG).
Who is sponsoring clinical trial NCT01288430?
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 NCT01288430's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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