A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection 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: June 6, 2012
Last verified: June 2012

March 16, 2009
June 6, 2012
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 Doxorubicin Hydrochloride Liposome Injection in Patients With Multiple Myeloma
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection- Test and Reference, 2mg/ml (30 mg/m2 Dose) in Patients With Multiple Myeloma

This study is planned to monitor safety and assess bioequivalence of Doxorubicin Hydrochloride Liposome injection- Test and Reference, administered as 2 mg/ml injection (30 mg/m2 dose) in patients with Multiple myeloma. Patients will receive Test and Reference drug with an interval of 21 days between the doses. In this study, blood samples will be collected during and after the infusion.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Multiple Myeloma
  • Drug: Doxorubicin Hydrochloride Liposome Injection- Test
    Doxorubicin Hydrochloride Liposome Injection 2 mg/mL, dose 30 mg/mL, 1 injection
  • Drug: Doxorubicin Hydrochloride Liposome Injection- Reference
    Doxorubicin Hydrochloride Liposome Injection 2 mg/mL, dose 30 mg/mL, 1 injection
  • Experimental: 1
    Doxorubicin Hydrochloride Liposome Injection 2 mg/mL- Test
    Intervention: Drug: Doxorubicin Hydrochloride Liposome Injection- Test
  • Active Comparator: 2
    Doxorubicin Hydrochloride Liposome Injection 2 mg/mL
    Intervention: Drug: Doxorubicin Hydrochloride Liposome Injection- Reference
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)
  • Informed consent form given in written form according
  • Female patients of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies,diaphragm, intrauterine device (IUD), or abstinence postmenopausal for at least 1 year surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

History or presence of significant:

  • Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride
  • Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
  • Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
  • Smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
  • Positive result to HIV, HCV, RPR and HBsAg.
  • 12 lead ECG, X-ray and 2D-Echocardiography finding.

Patients shall be excluded for any of the following laboratory results:

  • Donation of 350 mL or more of blood in the last 90 days
  • Participation in another clinical trial within the preceding 90 days of study start
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
Sun Pharma Advanced Research Company Limited
Sun Pharma Advanced Research Company Limited
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
June 2012

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