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Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862355
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Brief Summary:
Bioequivalence study of SPARC147609

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Drug: SPARC147609 Drug: Reference147609 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : March 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: 1
SPARC147609
Drug: SPARC147609
IV infusion

Active Comparator: 2
Reference147609
Drug: Reference147609
IV infusion




Primary Outcome Measures :
  1. 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product [ Time Frame: 2 cycles ]

Secondary Outcome Measures :
  1. Treatment emergent adverse events [ Time Frame: 2 cycles ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862355


Locations
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India
SPARC Site 1
Hyderabaad, Andhra Pradesh, India
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT00862355    
Other Study ID Numbers: DOX_2I_1476_09
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Keywords provided by Sun Pharma Advanced Research Company Limited:
Carcinoma
Ovary
Carcinoma Ovary
Additional relevant MeSH terms:
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Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms