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A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SPARC147709
Reference147709
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Myeloma focused on measuring Multiple myeloma, Bio-equivalence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    SPARC147709

    Reference147709

    Outcomes

    Primary Outcome Measures

    90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference

    Secondary Outcome Measures

    Treatment Emergent Adverse Events

    Full Information

    First Posted
    March 16, 2009
    Last Updated
    May 2, 2019
    Sponsor
    Sun Pharma Advanced Research Company Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00863174
    Brief Title
    A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma
    Official Title
    A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of SPARC_147709- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    January 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Pharma Advanced Research Company Limited

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Safety and bioequivalence of SPARC_147709

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    Multiple myeloma, Bio-equivalence

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    SPARC147709
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Reference147709
    Intervention Type
    Drug
    Intervention Name(s)
    SPARC147709
    Intervention Description
    SPARC147709 injection
    Intervention Type
    Drug
    Intervention Name(s)
    Reference147709
    Intervention Description
    Reference147709 injection
    Primary Outcome Measure Information:
    Title
    90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference
    Time Frame
    2 cycles
    Secondary Outcome Measure Information:
    Title
    Treatment Emergent Adverse Events
    Time Frame
    2 cycles

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

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