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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.

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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

FieldValue
Enrollment Target 54 participants
Start Date 2013-05
Est. Completion 2014-12
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.