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

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.

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Key information

Conditions

Breast Cancer and Ovarian Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

SPARC-08-038

Drug

2 mg/ml intravenous infusion

Ref-08-038

Drug

2 mg/ml intravenous infusion

Primary outcomes

Maximum measured plasma concentration

Time frame: 336 hours

Secondary outcomes

The area under the plasma concentration versus time curve from time 0 to infinity

Time frame: 336 hours

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Official study title

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.

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Feb 16, 2017
Registry last updated: Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed