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NCT01195311 · ClinicalTrials.gov registry record · Phase 1
A Dose-escalation Study in Subjects With Advanced Malignancies
A Phase 1 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01195311: Completed Phase 1 study, sponsored by Incyte Corporation.
NCT01195311 is a Phase 1 study that has completed, run by Incyte Corporation. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01195311, a Phase 1 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects. An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.
Interventions
- DRUG INCB024360
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
What the finished NCT01195311 record still lists
NCT01195311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which INCB024360 is the first listed.
NCT01195311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01195311 about?
NCT01195311 is a clinical study titled "A Dose-escalation Study in Subjects With Advanced Malignancies". This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next gro...
What is the current status of trial NCT01195311?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2010-07. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01195311?
The interventions under investigation include: INCB024360 (DRUG).
Who is sponsoring clinical trial NCT01195311?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01195311's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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