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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03055143
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer and Ovarian Cancer Drug: SPARC-08-038 Drug: Ref-08-038 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : September 3, 2008
Actual Primary Completion Date : November 28, 2009
Actual Study Completion Date : November 28, 2009

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

Primary Outcome Measures :
  1. Maximum measured plasma concentration [ Time Frame: 336 hours ]

Secondary Outcome Measures :
  1. The area under the plasma concentration versus time curve from time 0 to infinity [ Time Frame: 336 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT03055143    
Other Study ID Numbers: PKD/08/038
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type