Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02136927
• Other study ID #: CLR_12_10
• Status: Terminated
• Phase: Phase 1
• Start date: August 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2019
• Source: Sun Pharma Advanced Research Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pharmacokinetic, bioequivalence study

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• SPARC1210

• Reference1210

Locations

Country	Name	City	State
India	SPARC Site 10	Chennai	Tamil Nadu
India	SPARC Site 8	Cochin	Kerala
India	SPARC Site 2	Goraj	Gujarat
India	SPARC Site 12	Hyderabad	Andhra Pradesh
India	SPARC Site 9	Hyderabad	Andhra Pradesh
India	SPARC Site 7	Madurai	Tamil Nadu
India	SPARC Site 11	Mumbai	Maharashtra
India	SPARC Site 5	Nagpur	Maharashtra
India	SPARC Site 4	Nashik	Maharashtra
India	SPARC Site 6	New Delhi	Delhi
India	SPARC Site 1	Pune	Maharashtra
India	SPARC Site 3	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	AEs encountered following dosing with PICN or Abraxane® will be recorded as per CTCAE, Version 4.0	Day 3
Primary	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