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A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer

NCT01815294 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-12-04

No results posted yet for this study

Summary

The purpose of this study is to support the qualification of a replacement manufacturing site for DOXIL/CAELYX (doxorubicin HCL).

Conditions

  • Neoplasms
  • Neoplasms, Ovarian
  • Neoplasms, Breast
  • Advanced or Refractory Solid Malignancies

Interventions

DRUG

DOXIL/CAELYX (doxorubicin) Treatment Sequence AB

Cycle 1 = Treatment A, Cycle 2 = Treatment B

DRUG

DOXIL/CAELYX (doxorubicin) Treatment Sequence BA

Cycle 1 = Treatment B, Cycle 2 = Treatment A

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Belgium
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01815294 on ClinicalTrials.gov