A Study of DOXIL/CAELYX in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer

NCT02081495 | Completed Phase 1

• 3 other identifiers: CR103500DOXILNAP10042013-004641-16
• Study Type: interventional
• Target: 35
• Locations: 4 countries
• Sites: 6

Brief Summary

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

Conditions

Neoplasms

Keywords

Neoplasms; Neoplasms, Ovarian; Ovarian Cancer; Advanced or Refractory Solid Malignancies; Doxorubicin; DOXIL; CAELYX

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax) of encapsulated doxorubicin

  Cmax is defined as the maximum observed analyte concentration.

  Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

• Time to reach the maximum observed plasma concentration (Tmax) of encapsulated doxorubicin

  Tmax is defined as the actual sampling time to reach maximum observed analyte concentration.

  Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

• Area under the plasma concentration-time curve from time 0 to infinite time (AUC[0-infinity]) of encapsulated doxorubicin

  AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of the Area Under the Curve (AUC) last and AUC(last)/lambda, in which AUC(last) is the last observed quantifiable concentration.

  Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

Secondary Outcomes (5)

• Maximum observed plasma concentration (Cmax) of free doxorubicin

  Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

• Time to reach the maximum observed plasma concentration (T max) of free doxorubicin

  Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

• Area under the plasma concentration-time curve from time 0 to infinite time (AUC[0 - infinity]) of free doxorubicin

  Predose, and postdose Day 1 (Minutes 15, 30, 60, 90, 95, 105; Hours 2, 3, 4, 6, 8), Days 2, 3, 4, 5, 8, 15, 22, and 26 (for Cycles 1 and 2)

• Number of participants with adverse events as a measure of safety and tolerability

  Up to Day 86

• Number of participants with response to the study medication at End-of-Treatment visit (Day 58)

  Day 58 or 30 days after the last dose of the study medication for early withdrawal participants

Study Arms (2)

Sequence AB

EXPERIMENTAL

Twenty-one participants will receive DOXIL/CAELYX reference product in Cycle 1 and DOXIL/CAELYX test product in Cycle 2. Each cycle will be separated by 28 days.

Drug: DOXIL/CAELYX reference product (Treatment A); Drug: DOXIL/CAELYX test product (Treatment B)

Sequence BA

EXPERIMENTAL

Twenty-one participants will receive DOXIL/CAELYX test product in Cycle 1 and DOXIL/CAELYX reference product in Cycle 2. Each cycle will be separated by 28 days.

Drug: DOXIL/CAELYX reference product (Treatment A); Drug: DOXIL/CAELYX test product (Treatment B)

Interventions

DOXIL/CAELYX reference product (Treatment A) DRUG

Participants will receive DOXIL/CAELYX reference product 50 mg/m2 as an intravenous (into a vein) infusion over 90 minutes on Day 1.

Also known as: DOXIL, CAELYX

Sequence AB; Sequence BA

DOXIL/CAELYX test product (Treatment B) DRUG

Participants will receive DOXIL/CAELYX test product 50 mg/m2 as an intravenous infusion over 90 minutes on Day 1.

Also known as: DOXIL, CAELYX

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having advanced or refractory solid malignancies (histologically or cytologically confirmed advanced ovarian cancer failing platinum-based chemotherapy or metastatic breast cancer after failing approved life prolonging therapies or any solid malignancy that is metastatic or unresectable, and for which standard treatment is no longer an option)
• Eastern cooperative oncology group performance status 0 to 2
• Recovered from the acute toxicity (except alopecia and asymptomatic neuropathy) of any prior treatment
• Participants with prior doxorubicin (or other anthracyclines) or without any prior anthracylin exposure can also be included
• Agrees to protocol-defined use of effective contraception

You may not qualify if:

• Positive history of known brain metastases or leptomeningeal disease (spreading of cancer throughout the protective membranes covering the brain and spinal cord). Participants with brain metastases can only be enrolled if the following conditions are all met: 1) Brain metastases have been treated and stable for more than 4 weeks, 2) No evidence for progression or hemorrhage after treatment, 3) Steroid treatment was discontinued at least 2 weeks prior to first administration of DOXIL/CAELYX, and 4) Enzyme inducing anti-epileptic medicines were discontinued at least 4 weeks before first administration of DOXIL/CAELYX
• Use of an investigational medicine within 21 days or 5 half-lives (whichever is shorter) prior to the first dose of DOXIL/CAELYX
• Any major surgery, radiotherapy, or immunotherapy within the last 21 days. Chemotherapy regimens with delayed toxicity within the last 3 weeks (or within the last 6 weeks for prior nitrosourea or mitomycin C)
• Unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure or any history of uncontrolled cardiac disease
• Having an uncontrolled infection and uncontrolled concurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that may potentially impair the participant's compliance with study procedures

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (6)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Wilrijk, Belgium

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Related Links

• A Pivotal Bioequivalence Study of DOXIL®/CAELYX® Manufactured at a New Site in Subjects with Advanced or Refractory Solid Malignancies

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 11, 2016

Record last verified: 2016-10

Locations

BE (2); US (1); ES (2); CA (1)