A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection in Patients With Multiple Myeloma

This study is not yet open for participant recruitment.

Verified by Sun Pharma Advanced Research Company Limited, March 2009

First Received: March 16, 2009 No Changes Posted

Sponsored by:	Sun Pharma Advanced Research Company Limited
Information provided by:	Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:	NCT00863174

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 I

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
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

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 ]

Estimated Enrollment:	24
Study Start Date:	July 2010
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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:	MNJ Institute of Oncology & Regional Cancer Center ( A.V.S. Suresh )
Study ID Numbers:	DOX_21_1477_09
Study First Received:	March 16, 2009
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00863174 History of Changes
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

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Doxorubicin
Multiple Myeloma
Anti-Bacterial Agents
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias
Antibiotics, Antineoplastic
Hemostatic Disorders

Pharmacologic Actions
Doxorubicin
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009