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NCT01815294 · ClinicalTrials.gov registry record · Phase 1
A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01815294: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT01815294 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815294, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The purpose of this study is to support the qualification of a replacement manufacturing site for DOXIL/CAELYX (doxorubicin HCL).
Interventions
- DRUG DOXIL/CAELYX (doxorubicin) Treatment Sequence AB
- DRUG DOXIL/CAELYX (doxorubicin) Treatment Sequence BA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT01815294 record still lists
NCT01815294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which DOXIL/CAELYX (doxorubicin) Treatment Sequence AB is the first listed.
NCT01815294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01815294 about?
NCT01815294 is a clinical study titled "A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer". The purpose of this study is to support the qualification of a replacement manufacturing site for DOXIL/CAELYX (doxorubicin HCL).
What is the current status of trial NCT01815294?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2013-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01815294?
The interventions under investigation include: DOXIL/CAELYX (doxorubicin) Treatment Sequence AB (DRUG), DOXIL/CAELYX (doxorubicin) Treatment Sequence BA (DRUG).
Who is sponsoring clinical trial NCT01815294?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01815294's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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