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Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

Primary Purpose

Ovarian Epithelial Cancer Recurrent

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Doxorubicin Hydrochloride Liposome Injection
Sponsored by
Dr. Reddy's Laboratories Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Epithelial Cancer Recurrent

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 :

    1. Unstable angina
    2. QTc prolongation or other significant ECG abnormalities
    3. 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

Sites / Locations

  • City Cancer Center
  • Nirmal Hospital Pvt Ltd
  • Srinivasam Cancer Care Hospitals India Private Limited
  • Erode Cancer Center
  • Cancer Clinic and Nursing Home & Jasleen Hospital
  • Curie Manavta Cancer Centre
  • Acharya HariHar Regional Cancer Centre
  • Meenakshi Mission Hospital & Research Centre
  • Dr. G. Viswanathan Speciality Hospitals
  • Bibi General Hospital
  • MNJ Institute of Oncology & Regional Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Product - T

Reference Product - R

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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)
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

Secondary Outcome Measures

Incidence of treatment-emergent adverse events ( TEAEs)

Full Information

First Posted
September 22, 2014
Last Updated
September 22, 2016
Sponsor
Dr. Reddy's Laboratories Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02260544
Brief Title
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
Official Title
A Multicenter, Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Cross-over Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 20mg/10mL of Dr. Reddy's Laboratories Ltd, India, With That of Doxorubicin Hydrochloride Liposome Injection 20 mg/10mL , Manufactured by: Sun Pharmaceutical Ind. Ltd, India; in Ovarian Cancer Patients Whose Disease Has Progressed or Recurred After Platinum Based Chemotherapy and Who Are Already Receiving or Scheduled to Start Therapy With the Reference Listed Drug Under Fasting Condition.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .
Detailed Description
This study has sequential two stage design. Bioequivalence based on encapsulated doxorubicin will be tested at the end of stage 1. Power analysis will be performed for the primary pharmacokinetic parameters of free Doxorubicin and liposome encapsulated Doxorubicin, for all completed patients before bioequivalence evaluation. If observed power will be >= 80% then two one-sided 90% CI will be calculated for bioequivalence assessment at stage I. If observed power will be < 80% then bioequivalence will be evaluated at stage I. If bioequivalence met then study will be stopped and if bioequivalence not met, then required additional patients will be enrolled in stage II. Each patient will be randomized to one of the two treatment sequences ( RT or TR ) according to a randomization scheme prepared prior to the start of the trial. Serial blood samples for determination of free doxorubicin and liposomal encapsulated doxorubicin plasma concentration for PK analysis will be obtained in each cycle . Bioequivalence Criteria : The 94.12% confidence intervals for the ratio of geometric least squares means of ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf should be within 80.00 to125.00% to conclude the test product is bioequivalent to the reference product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Epithelial Cancer Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Product - T
Arm Type
Experimental
Arm Description
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.
Arm Title
Reference Product - R
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin Hydrochloride Liposome Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacokinetic ( PK ) parameter : the maximum plasma doxorubicin concentration ( Cmax ) [ Time frame : 2 cycles ]
Description
The study end point will use PK parameter ( Cmax ) for free doxorubicin and liposome encapsulated doxorubicin
Time Frame
58 days
Title
PK parameter : the areas under the plasma concentration versus time curve calculated from 0 to the last measurable observation ( AUC 0-t)
Description
The study endpoint will use the PK parameter ( AUC 0-t) for free doxorubicin and liposome encapsulated doxorubicin ( AUC 0-t)
Time Frame
58 days
Title
PK parameter : the areas under the plasma concentration versus time curve extrapolated from 0 to infinity ( AUC 0-inf)
Description
The study endpoint will use the PK parameter ( AUC 0-Inf) for free doxorubicin and liposome encapsulated doxorubicin
Time Frame
58 days
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events ( TEAEs)
Time Frame
58 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashis Patnaik, MBBS, MD
Organizational Affiliation
Dr. Reddy's Laboratories Limited
Official's Role
Study Director
Facility Information:
Facility Name
City Cancer Center
City
Vijaywada
State/Province
Andhra Pradesh
Country
India
Facility Name
Nirmal Hospital Pvt Ltd
City
Surat
State/Province
Gujarat
Country
India
Facility Name
Srinivasam Cancer Care Hospitals India Private Limited
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Erode Cancer Center
City
Erode
State/Province
Karnataka
Country
India
Facility Name
Cancer Clinic and Nursing Home & Jasleen Hospital
City
Nagpur
State/Province
Maharahtra
Country
India
Facility Name
Curie Manavta Cancer Centre
City
Nashik
State/Province
Maharashtra
Country
India
Facility Name
Acharya HariHar Regional Cancer Centre
City
Cuttack
State/Province
Orissa
Country
India
Facility Name
Meenakshi Mission Hospital & Research Centre
City
Madurai
State/Province
Tamil Nadu
Country
India
Facility Name
Dr. G. Viswanathan Speciality Hospitals
City
Trichy
State/Province
Tamil Nadu
Country
India
Facility Name
Bibi General Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Facility Name
MNJ Institute of Oncology & Regional Cancer Centre
City
Hyderabad
State/Province
Telangana
Country
India

12. IPD Sharing Statement

Links:
URL
http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9255&EncHid=&userName=
Description
CTRI web site India

Learn more about this trial

Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection

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