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NCT01478685 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 169
- Enrollment target
NCT01478685: Completed Phase 1 study, sponsored by Celgene.
NCT01478685 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 169 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (182% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01478685, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 169 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in subjects with relapsed or refractory solid tumors.
Primary Outcome
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity.
Interventions
- DRUG Carboplatin
- DRUG CC-486
- DRUG ABI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2011-11-29 |
| Est. Completion | 2015-11-17 |
| Phase | Phase 1 |
What the finished NCT01478685 record still lists
NCT01478685 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (182% higher).
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT01478685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01478685 about?
NCT01478685 is a clinical study titled "A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors". The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in subjects with relapsed or ...
What is the current status of trial NCT01478685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 169 participants. The study started on 2011-11-29. Estimated completion is 2015-11-17.
What interventions are being tested in trial NCT01478685?
The interventions under investigation include: Carboplatin (DRUG), CC-486 (DRUG), ABI-007 (DRUG).
Who is sponsoring clinical trial NCT01478685?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01478685's enrollment target sits among peer trials
169 326th of 2000 higher than 1,675 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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