A Bioequivalence Study of SPARC_147709 in Patients With M... | NCT00863174

Studies
A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

NCT00863174

Sponsor

Sun Pharma Advanced Research Company Limited

Status

Completed

Last Update Posted

May 3, 2019Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Multiple Myeloma

Interventions

SPARC147709
Reference147709

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

Status Module

Record Verification Date

May 2019

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

Nov 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Mar 16, 2009

First Submission Date that Met QC Criteria

Mar 16, 2009

First Posted Date

Mar 17, 2009Estimated

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	SPARC147709	Drug: SPARC147709
2	Active Comparator	Reference147709	Drug: Reference147709

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPARC147709	Drug	SPARC147709 injection	1
Reference147709

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference		2 cycles

Secondary Outcomes

Measure	Description	Time Frame
Treatment Emergent Adverse Events		2 cycles

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Availability for the entire study period and willingness to adhere to protocol requirements.
Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
18 years of age or older
No evidence of underlying disease (except multiple myeloma)

Exclusion Criteria:

History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride
History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
Positive result to HIV, HCV, RPR and HBsAg.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided