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
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Doxorubicin Hydrochloride Liposome Injection- Test
Drug: Doxorubicin Hydrochloride Liposome Injection- Reference
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Treatment Emergent Adverse Events [ Time Frame: 2 cycles ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: November 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Doxorubicin Hydrochloride Liposome Injection 2 mg/mL- Test
Drug: Doxorubicin Hydrochloride Liposome Injection- Test
Doxorubicin Hydrochloride Liposome Injection 2 mg/mL, dose 30 mg/mL, 1 injection
Active Comparator: 2
Doxorubicin Hydrochloride Liposome Injection 2 mg/mL
Drug: Doxorubicin Hydrochloride Liposome Injection- Reference
Doxorubicin Hydrochloride Liposome Injection 2 mg/mL, dose 30 mg/mL, 1 injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT00863174     History of Changes
Other Study ID Numbers: DOX_21_1477_09
Study First Received: March 16, 2009
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Sun Pharma Advanced Research Company Limited:
Multiple myeloma
Doxorubicin
Bio-equivalence

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014