Back to resultsBioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
SPARC1210
Reference1210
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- The subject has given written, informed consent and is available for the entire study.
- Histologically or cytologically confirmed diagnosis of breast cancer;
- Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
- Age 18 years or more
Exclusion Criteria:
- Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
- Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
- Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
- Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
Sites / Locations
- SPARC Site 12
- SPARC Site 9
- SPARC Site 6
- SPARC Site 2
- SPARC Site 8
- SPARC Site 11
- SPARC Site 5
- SPARC Site 4
- SPARC Site 1
- SPARC Site 3
- SPARC Site 10
- SPARC Site 7
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SPARC1210
Reference1210
Arm Description
Intravenous administration of SPARC1210
Intravenous administration of Reference1210
Outcomes
Primary Outcome Measures
Maximum observed concentration (Cmax)
Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.
Secondary Outcome Measures
Full Information
NCT ID
NCT02136927
First Posted
May 9, 2014
Last Updated
May 2, 2019
Sponsor
Sun Pharma Advanced Research Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02136927
Brief Title
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (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
Pharmacokinetic, bioequivalence study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPARC1210
Arm Type
Experimental
Arm Description
Intravenous administration of SPARC1210
Arm Title
Reference1210
Arm Type
Active Comparator
Arm Description
Intravenous administration of Reference1210
Intervention Type
Drug
Intervention Name(s)
SPARC1210
Intervention Type
Drug
Intervention Name(s)
Reference1210
Primary Outcome Measure Information:
Title
Maximum observed concentration (Cmax)
Description
Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.
Time Frame
Pre-dose, post-dose up to 3 days
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
AEs encountered following dosing with PICN or Abraxane® will be recorded as per CTCAE, Version 4.0
Time Frame
Day 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject has given written, informed consent and is available for the entire study.
Histologically or cytologically confirmed diagnosis of breast cancer;
Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
Age 18 years or more
Exclusion Criteria:
Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study
Facility Information:
Facility Name
SPARC Site 12
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
SPARC Site 9
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
SPARC Site 6
City
New Delhi
State/Province
Delhi
Country
India
Facility Name
SPARC Site 2
City
Goraj
State/Province
Gujarat
Country
India
Facility Name
SPARC Site 8
City
Cochin
State/Province
Kerala
Country
India
Facility Name
SPARC Site 11
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
SPARC Site 5
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
SPARC Site 4
City
Nashik
State/Province
Maharashtra
Country
India
Facility Name
SPARC Site 1
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
SPARC Site 3
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
SPARC Site 10
City
Chennai
State/Province
Tamil Nadu
Country
India
Facility Name
SPARC Site 7
City
Madurai
State/Province
Tamil Nadu
Country
India
12. IPD Sharing Statement
Learn more about this trial
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
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