Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

NCT02260544 | Completed Phase 1

• 1 other identifier: 591-13
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 11

Brief Summary

Bioequivalence study is proposed to be carried out on patients of ovarian cancer, who are already receiving or who in the opinion of their treating physicians are candidates for Doxorubicin liposomal injection therapy .

Conditions

Ovarian Epithelial Cancer Recurrent

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic ( PK ) parameter : the maximum plasma doxorubicin concentration ( Cmax ) [ Time frame : 2 cycles ]

  The study end point will use PK parameter ( Cmax ) for free doxorubicin and liposome encapsulated doxorubicin

  58 days

• PK parameter : the areas under the plasma concentration versus time curve calculated from 0 to the last measurable observation ( AUC 0-t)

  The study endpoint will use the PK parameter ( AUC 0-t) for free doxorubicin and liposome encapsulated doxorubicin ( AUC 0-t)

  58 days

• PK parameter : the areas under the plasma concentration versus time curve extrapolated from 0 to infinity ( AUC 0-inf)

  The study endpoint will use the PK parameter ( AUC 0-Inf) for free doxorubicin and liposome encapsulated doxorubicin

  58 days

Secondary Outcomes (1)

• Incidence of treatment-emergent adverse events ( TEAEs)

  58 days

Study Arms (2)

Test Product - T

EXPERIMENTAL

doxorubicin hydrochloride liposome ( Dr. Reddy's Lab ) Use the test drug (doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Dr.Reddy's Laboratories Ltd., India) ; then use the reference drug ( doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Sun Pharma ) after at least 4-weeks.

Drug: Doxorubicin Hydrochloride Liposome Injection

Reference Product - R

ACTIVE COMPARATOR

doxorubicin hydrochloride liposome ( Sun Pharma ) Use the reference drug (doxorubicin Hydrochloride Liposome Injection 20mg/10mL i.e. 2mg/mL; from Sun Pharma ) ; then use the test drug ( doxorubicin hydrochloride liposome Injection 20mg/10mL i.e. 2mg/mL from Dr.Reddy's Laboratories Ltd., India) after at least 4 weeks.

Drug: Doxorubicin Hydrochloride Liposome Injection

Interventions

Doxorubicin Hydrochloride Liposome Injection DRUG

50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation , After completion of Cycle 2 ( Day 28) , patients will be continued on the treatment of Doxorubicin Hydrochloride Liposome injection upto 4 more cycles if tolerance permits under guidance of their attending physicians.

Reference Product - R; Test Product - T

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female of Indian Nationality , between 18-60n years of age
• Able to understand investigational nature of this study and give written informed consent prior to the participation in the trial.
• Patients with ovarian cancer requiring Doxorubicin and whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy with reference listed drug
• ECOG performance status ≤ 2
• Cardiac function ( LVEF) ≥ 50%
• patient with life expectancy of at least 3 months
• Adequate hematopoietic, renal and liver function

You may not qualify if:

• Prior doxorubicin exposure that would result in a total lifetime exposure of 550mg/m2 or more after four cycles of treatment .
• Pregnant or breast-feeding female
• active opportunistic infection with mycobacteria , cytomegalovirus , toxoplasma
• Impaired cardiac function including any of the following conditions within past 6 months :
• Unstable angina
• QTc prolongation or other significant ECG abnormalities
• Coronary artery bypass graft surgery
• History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCl or the components of Doxorubicin Hydrochloride liposome injection.
• known brain metastasis
• HIV positive antibody or syphilis
• Patients with significantly impaired hepatic function
• Clinically significant liver and kidney disease

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (11)

City Cancer Center

Vijaywada, Andhra Pradesh, India

Location

Nirmal Hospital Pvt Ltd

Surat, Gujarat, India

Location

Srinivasam Cancer Care Hospitals India Private Limited

Bangalore, Karnataka, India

Location

Erode Cancer Center

Erode, Karnataka, India

Location

Cancer Clinic and Nursing Home & Jasleen Hospital

Nagpur, Maharahtra, India

Location

Curie Manavta Cancer Centre

Nashik, Maharashtra, India

Location

Acharya HariHar Regional Cancer Centre

Cuttack, Odisha, India

Location

Meenakshi Mission Hospital & Research Centre

Madurai, Tamil Nadu, India

Location

Dr. G. Viswanathan Speciality Hospitals

Trichy, Tamil Nadu, India

Location

Bibi General Hospital

Hyderabad, Telangana, 500034, India

Location

MNJ Institute of Oncology & Regional Cancer Centre

Hyderabad, Telangana, India

Location

Related Links

• CTRI web site India

Study Officials

• Ashis Patnaik, MBBS, MD

  Dr. Reddy's Laboratories Limited

  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: September 22, 2014
• First Posted: October 9, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

IN (11)