Bioavailability Study of SPARC1210 and Reference1210 in S... | NCT02136927

Studies
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer

NCT02136927

Sponsor

Sun Pharma Advanced Research Company Limited

Status

Terminated

Last Update Posted

May 3, 2019Actual

Enrollment

33Actual

Phase

Phase 1

Conditions

Breast Cancer

Interventions

SPARC1210
Reference1210

Countries

India

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

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

May 9, 2014

First Submission Date that Met QC Criteria

May 9, 2014

First Posted Date

May 13, 2014Estimated

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

May 2, 2019

Last Update Posted Date

May 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPARC1210	Experimental	Intravenous administration of SPARC1210	Drug: SPARC1210
Reference1210	Active Comparator	Intravenous administration of Reference1210	Drug: Reference1210

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPARC1210	Drug		SPARC1210
Reference1210

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed concentration (Cmax)	Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.	Pre-dose, post-dose up to 3 days

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Adverse events	AEs encountered following dosing with PICN or Abraxane® will be recorded as per CTCAE, Version 4.0	Day 3

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject has given written, informed consent and is available for the entire study.
Histologically or cytologically confirmed diagnosis of breast cancer;
Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
Age 18 years or more

Exclusion Criteria:

Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SPARC Site 12		Hyderabad	Andhra Pradesh		India
SPARC Site 9

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided