A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT00863174
First received: March 16, 2009
Last updated: March 8, 2016
Last verified: March 2016

March 16, 2009
March 8, 2016
November 2010
January 2011   (final data collection date for primary outcome measure)
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference [ Time Frame: 2 cycles ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00863174 on ClinicalTrials.gov Archive Site
Treatment Emergent Adverse Events [ Time Frame: 2 cycles ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma
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
Safety and bioequivalence of SPARC_147709
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Multiple Myeloma
  • Drug: SPARC147709
    SPARC147709 injection
  • Drug: Reference147709
    Reference147709 injection
  • Experimental: 1
    SPARC147709
    Intervention: Drug: SPARC147709
  • Active Comparator: 2
    Reference147709
    Intervention: Drug: Reference147709
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00863174
DOX_21_1477_09
No
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
Sun Pharma Advanced Research Company Limited
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP