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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 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 54 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01815294
The ClinicalTrials.gov registry entry for NCT01815294 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DOXIL/CAELYX (doxorubicin) Treatment Sequence AB is the first listed.
NCT01815294 reports 0 study locations.
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.
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