Study of Doxorubicin in Patients With Metastatic Breast C... | NCT03055143

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

NCT03055143

Sponsor

Sun Pharma Advanced Research Company Limited

Status

Completed

Last Update Posted

Jul 23, 2021Actual

Enrollment

29Actual

Phase

Phase 1

Conditions

Breast Cancer and Ovarian Cancer

Interventions

SPARC-08-038
Ref-08-038

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2008Actual

Primary Completion Date

Nov 28, 2009Actual

Completion Date

Nov 28, 2009Actual

First Submitted Date

Feb 7, 2017

First Submission Date that Met QC Criteria

Feb 15, 2017

First Posted Date

Feb 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2021

Last Update Posted Date

Jul 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPARC-08-038	Experimental	2 mg/ml	Drug: SPARC-08-038 Drug: Ref-08-038
Ref-08-038	Active Comparator		Drug: SPARC-08-038 Drug: Ref-08-038

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPARC-08-038	Drug	2 mg/ml intravenous infusion	Ref-08-038 SPARC-08-038

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum measured plasma concentration		336 hours

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29995186	Derived	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.

ID	Term
D001943	Breast Neoplasms
D010051	Ovarian Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases