Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
1 other identifier
interventional
33
1 country
12
Brief Summary
Pharmacokinetic, bioequivalence study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 breast-cancer
Started Aug 2014
Shorter than P25 for phase_1 breast-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 3, 2019
May 1, 2019
1.7 years
May 9, 2014
May 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum observed concentration (Cmax)
Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.
Pre-dose, post-dose up to 3 days
Other Outcomes (1)
Adverse events
Day 3
Study Arms (2)
SPARC1210
EXPERIMENTALIntravenous administration of SPARC1210
Reference1210
ACTIVE COMPARATORIntravenous administration of Reference1210
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
SPARC Site 12
Hyderabad, Andhra Pradesh, India
SPARC Site 9
Hyderabad, Andhra Pradesh, India
SPARC Site 2
Goraj, Gujarat, India
SPARC Site 8
Kochi, Kerala, India
SPARC Site 11
Mumbai, Maharashtra, India
SPARC Site 5
Nagpur, Maharashtra, India
SPARC Site 4
Nashik, Maharashtra, India
SPARC Site 1
Pune, Maharashtra, India
SPARC Site 3
Pune, Maharashtra, India
SPARC Site 6
New Delhi, National Capital Territory of Delhi, India
SPARC Site 10
Chennai, Tamil Nadu, India
SPARC Site 7
Madurai, Tamil Nadu, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2014
First Posted
May 13, 2014
Study Start
August 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
May 3, 2019
Record last verified: 2019-05