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

Primary Purpose

Breast Cancer and Ovarian Cancer

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

SPARC-08-038

Ref-08-038

About this trial

This is an interventional treatment trial for Breast Cancer and Ovarian Cancer

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPARC-08-038

Ref-08-038

Arm Description

2 mg/ml

Outcomes

Primary Outcome Measures

Maximum measured plasma concentration

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03055143

First Posted

February 7, 2017

Last Updated

July 22, 2021

Sponsor

Sun Pharma Advanced Research Company Limited

1. Study Identification

Unique Protocol Identification Number

NCT03055143

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

September 3, 2008 (Actual)

Primary Completion Date

November 28, 2009 (Actual)

Study Completion Date

November 28, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sun Pharma Advanced Research Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer and Ovarian Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SPARC-08-038

Arm Type

Experimental

Arm Description

2 mg/ml

Arm Title

Ref-08-038

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

SPARC-08-038

Intervention Description

2 mg/ml intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Ref-08-038

Intervention Description

2 mg/ml intravenous infusion

Primary Outcome Measure Information:

Title

Maximum measured plasma concentration

Time Frame

336 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

336 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29995186

Citation

Bhowmik S, Bhowmick S, Maiti K, Chakra A, Shahi P, Jain D, Rajamannar T. Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil(R) or Caelyx(R) in advanced ovarian cancer. Cancer Chemother Pharmacol. 2018 Sep;82(3):521-532. doi: 10.1007/s00280-018-3643-3. Epub 2018 Jul 11.

Results Reference

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

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