A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00863174
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : March 9, 2016
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
Safety and bioequivalence of SPARC_147709

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: SPARC147709 Drug: Reference147709 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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 Start Date : November 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: 1
Drug: SPARC147709
SPARC147709 injection

Active Comparator: 2
Drug: Reference147709
Reference147709 injection

Primary Outcome Measures :
  1. 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference [ Time Frame: 2 cycles ]

Secondary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: 2 cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT00863174     History of Changes
Other Study ID Numbers: DOX_21_1477_09
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016

Keywords provided by Sun Pharma Advanced Research Company Limited:
Multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases