Completed

A Pivotal Bioequivalence Study of DOXIL/CAELYX Manufactured at a New Site in Subjects With Advanced or Refractory Solid Malignancies Including Subjects With Ovarian Cancer.

What is being tested

DOXIL/CAELYX (doxorubicin) Treatment Sequence AB

+ DOXIL/CAELYX (doxorubicin) Treatment Sequence BA

+ DOXIL/CAELYX (doxorubicin) Treatment Sequence AB

Drug

Who is being recruted

Urogenital Diseases+20

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: May 2013

See protocol details

Summary

Principal SponsorJanssen Research & Development, LLC

Last updated: December 4, 2015

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

This is a randomized (individuals will be assigned in a random order to study treatment sequences), open-label (identity of assigned treatment sequences will be known), single dose, 2-cycle, crossover (patients will receive both treatments in a random order) bioequivalence study of DOXIL/CAELYX (doxorubicin HCL) in patients with advanced or refractory solid malignancies (including patients with ovarian cancer). This study has an adaptive 2-stage design. Bioequivalence based on encapsulated doxorubicin will be tested at the end of Stage 1 using data from at least 24 ovarian cancer patients. An interim analysis of free doxorubicin will be performed at the end of Stage 1 using data from 42 patients of all cancer types. The study may continue into Stage 2 with additional patients of all cancer types; and final evaluation of bioequivalence for free doxorubicin will be performed at the end of Stage 2. The study will include a screening phase followed by an open-label treatment phase consisting of 2 doxorubicin treatment cycles and an end-of-treatment visit on Cycle 3, Day 1. Participants may enter an optional extension phase after 2 cycles. Safety will be monitored throughout the study. Blood samples for pharmacokinetic analysis will be obtained from all participants at specified times over 29 days after starting each study drug administration in Cycles 1 and 2 for determination of plasma concentrations of encapsulated and free doxorubicin.

NCT01815294

Principal SponsorJanssen Research & Development, LLC

Last updated: December 4, 2015

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesBreast DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasms by SiteNeoplastic ProcessesOvarian DiseasesPathologic ProcessesSkin DiseasesPathological Conditions, Signs and SymptomsUrogenital NeoplasmsSkin and Connective Tissue DiseasesFemale Urogenital DiseasesBreast NeoplasmsNeoplasm MetastasisNeoplasmsOvarian Neoplasms

Criteria

8 inclusion criteria required to participate

Adequate liver, bone marrow, and renal function according to protocol-defined parameters

Agrees to protocol-defined use of effective contraception

Diagnosed with advanced or refractory solid malignancies: histologically or cytologically confirmed advanced ovarian cancer failing platinum-based chemotherapy; histologically or cytologically confirmed metastatic breast cancer after failing approved life-prolonging therapies; any histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard treatment is no longer an option

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Show More Criteria

10 exclusion criteria prevent from participating

Any major surgery, radiotherapy, or immunotherapy within the last 21 days (limited palliative radiation allowed >= 2 weeks prior to the first dose; >= 4 weeks for whole brain radiotherapy); chemotherapy regimens with delayed toxicity within the last 4 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C); chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks

Concomitant use of strong CYP3A4 inhibitors (such as clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, nefazodone, ritonavir, telithromycin and verapamil) and strong CYP3A4 inducers (such as carbamazepine, phenobarbital, phenytoin, rifampin and St John's wort) from at least 4 weeks before the first dose of doxorubicin in Cycle 1 and until after completion of all pharmacokinetic sampling in Cycle 2

Has an infection that is either an uncontrolled infection, clinically important (occurred within 4 weeks prior to first dose of study agent), or requiring current systemic intravenous treatment

Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the patient or that could prevent, limit, or confound the protocol-specified assessments

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

50 mg/m2 of doxorubicin manufactured at the current site of manufacturing administered by IV infusion over 90 minutes on Day 1

Group II

Experimental

50 mg/m2 of doxorubicin manufactured at the new site of manufacturing (test product) administered by IV infusion over 90 minutes on Day 1

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Nashville, United StatesOpen in Google Maps

San Antonio, United States

Brussels, Belgium

Wilrijk, Belgium

Completed8 Study Centers