Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer

July 22, 2021 updated by: Sun Pharma Advanced Research Company Limited

A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.

This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
  2. Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
  3. Subjects who had no evidence of underlying disease
  4. Subjects who had signed written consent form

Exclusion Criteria:

  1. Females who were pregnant, breastfeeding, or are likely to become pregnant
  2. Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
  3. Subjects deemed uncooperative or noncompliant
  4. Smoking or consumption of any nicotine products

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPARC-08-038
2 mg/ml
Drug: SPARC-08-038
2 mg/ml intravenous infusion
Drug: Ref-08-038
2 mg/ml intravenous infusion
Active Comparator: Ref-08-038
Drug: SPARC-08-038
2 mg/ml intravenous infusion
Drug: Ref-08-038
2 mg/ml intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum measured plasma concentration
Time Frame: 336 hours
336 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The area under the plasma concentration versus time curve from time 0 to infinity
Time Frame: 336 hours
336 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2008

Primary Completion (Actual)

November 28, 2009

Study Completion (Actual)

November 28, 2009

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 22, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKD/08/038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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