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Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer

Primary Purpose

Ovarian Carcinoma

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
SPARC147609
Reference147609
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ovarian Carcinoma focused on measuring Carcinoma, Ovary, Carcinoma Ovary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • SPARC Site 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

SPARC147609

Reference147609

Outcomes

Primary Outcome Measures

90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product

Secondary Outcome Measures

Treatment emergent adverse events

Full Information

First Posted
March 13, 2009
Last Updated
May 2, 2019
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00862355
Brief Title
Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Bioequivalence study of SPARC147609

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma
Keywords
Carcinoma, Ovary, Carcinoma Ovary

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
SPARC147609
Arm Title
2
Arm Type
Active Comparator
Arm Description
Reference147609
Intervention Type
Drug
Intervention Name(s)
SPARC147609
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Reference147609
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product
Time Frame
2 cycles
Secondary Outcome Measure Information:
Title
Treatment emergent adverse events
Time Frame
2 cycles

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
SPARC Site 1
City
Hyderabaad
State/Province
Andhra Pradesh
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
29995186
Citation
Bhowmik S, Bhowmick S, Maiti K, Chakra A, Shahi P, Jain D, Rajamannar T. Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil(R) or Caelyx(R) in advanced ovarian cancer. Cancer Chemother Pharmacol. 2018 Sep;82(3):521-532. doi: 10.1007/s00280-018-3643-3. Epub 2018 Jul 11.
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Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer

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