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Sponsored by: |
Sun Pharma Advanced Research Company Limited |
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Information provided by: | Sun Pharma Advanced Research Company Limited |
ClinicalTrials.gov Identifier: | NCT00862355 |
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 |
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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 |
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 |
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1: Experimental
Liposomal Doxorubicin Hydrochloride Injection 2 mg/mL- Test
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Drug: Liposomal Doxorubicin Hydrochloride
Liposomal Doxorubicin Hydrochloride Injection 2 mg/mL, 50 mg/m2, Intravenous Infusion after dilution over a 60-minute period
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2: Active Comparator
Liposomal Doxorubicin Injection 2 mg/mL- Reference
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Drug: Liposomal Doxorubicin Hydrochloride Injection
Liposomal Doxorubicin Hydrochloride Injection 2 mg/mL, 50 mg/m2, Intravenous Infusion after dilution over a 60-minute period
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for enrollment in the study:
Exclusion Criteria:
History or presence of significant:
Subjects who have:
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 |
India, Andhra Pradesh | |
MNJ Institute of Oncology & Regional Cancer Center | |
Hyderabaad, Andhra Pradesh, India, 500004 |
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 |
Carcinoma Ovary Doxorubicin Carcinoma Ovary |
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 |
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 |