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A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection in Patients With Ovarian Cancer
This study is not yet open for participant recruitment.
Verified by Sun Pharma Advanced Research Company Limited, March 2009
First Received: March 13, 2009   No Changes Posted
Sponsored by: Sun Pharma Advanced Research Company Limited
Information provided by: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT00862355
  Purpose

This study is planned with the objective of evaluating the bioequivalence of two liposomal formulations of Doxorubicin hydrochloride injection in patients with ovarian cancer in addition to monitoring safety. Blood samples will be collected at specific timepoints during the study.


Condition Intervention Phase
Ovarian Carcinoma
Drug: Liposomal Doxorubicin Hydrochloride
Drug: Liposomal Doxorubicin Hydrochloride Injection
Phase I

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 Study to Monitor Safety and Assess Bioequivalence of Doxorubicin Hydrochloride Liposome Injection 2 mg/mL Test and Reference in Patients With Ovarian Cancer

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 product [ 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: April 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Liposomal Doxorubicin Hydrochloride Injection 2 mg/mL- Test
Drug: Liposomal Doxorubicin Hydrochloride
Liposomal Doxorubicin Hydrochloride Injection 2 mg/mL, 50 mg/m2, Intravenous Infusion after dilution over a 60-minute period
2: Active Comparator
Liposomal Doxorubicin Injection 2 mg/mL- Reference
Drug: Liposomal Doxorubicin Hydrochloride Injection
Liposomal Doxorubicin Hydrochloride Injection 2 mg/mL, 50 mg/m2, Intravenous Infusion after dilution over a 60-minute period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects meeting all of the following criteria will be considered for enrollment in the study:

    • Availability of subject for the entire study period and willingness to adhere to protocol requirements.
    • Patients with documented diagnosis of Ovarian Cancer and eligible for receiving a dose 50mg/m2 of Doxorubicin liposome(preferably on no other concomitant medication, however, if considered necessary, to be documented and given).
    • Patients at least 18-years of age or older. iv. Subjects who have no evidence of underlying disease (except ovarian cancer) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
    • Patients with Performance ≤ 2 on the ECOG performance scale. vi. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance.
    • Informed consent form given in written form.

Exclusion Criteria:

  • History or presence of significant:

    • Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc.
    • 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.
    • Clinically significant illness (except ovarian cancer)within 4 weeks before the start of the study v. Positive result to HIV, HCV, RPR and HBsAg.
    • Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study.
  • Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
  • Participation in another clinical trial within the preceding 90 days of study start
  • Subjects who have:

    • Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
    • Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
    • Pulse rate below 60/min. or above 100/min
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862355

Contacts
Contact: Shravanti Bhowmik, M.D. 91-22-66455645 ext 626 shravanti.bhowmik@sparcmail.com
Contact: Subhas Bhowmick, PhD 91-265-2350789 subhas.bhowmick@sparcmail.com

Locations
India, Andhra Pradesh
MNJ Institute of Oncology & Regional Cancer Center
Hyderabaad, Andhra Pradesh, India, 500004
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

No publications provided

Responsible Party: MNJ Institute of Oncology & Regional Cancer Center ( Dr. Malladi Ramakrishna )
Study ID Numbers: DOX_2I_1476_09
Study First Received: March 13, 2009
Last Updated: March 13, 2009
ClinicalTrials.gov Identifier: NCT00862355     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:
Carcinoma
Ovary
Doxorubicin
Carcinoma Ovary

Study placed in the following topic categories:
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Doxorubicin
Carcinoma
Genital Diseases, Female
Anti-Bacterial Agents
Ovarian Cancer
Endocrinopathy
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Carcinoma
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009