Pharmacokinetic study of SPARC1613 and Reference1613

Completed

• Conditions: Metastatic breast cancer

• Registration Number: CTRI/2016/12/007565
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

This was a multicenter, open-label, randomized, two-period, two treatment, single dose, crossover

bioequivalence study.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-29
• Study Completion: 2018-04-10
• Last Update Posted: 2019-10-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study 2.
• Histologically or cytologically confirmed diagnosis of breast cancer 3.
• Estimated life expectancy of at least 12 weeks 4.
• ECOG performance status less than 1.

Exclusion Criteria

• Known hypersensitivity to either of the study drugs or their excipients 2.
• Inability to undergo venipuncture and/or tolerate venous access 3.
• Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy 4.
• Pre-existing clinically significant peripheral neuropathy.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter Cmax, and AUC	Pharmacokinetic parameter Cmax, and AUC

Trial Locations

Locations (24)

Apple Hospital; 🇮🇳 Surat, GUJARAT, India

Curie Manavata Cancer Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Dept. of Radiation Therapy and Oncology, Govt. Medical College and Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Dr Rai Memorial Medical Centre; 🇮🇳 Chennai, TAMIL NADU, India

HCG Multi Speciliaty Ethic Committee; 🇮🇳 Ahmadabad, GUJARAT, India

Health Care Global Enterprises Ltd.; 🇮🇳 Bangalore, KARNATAKA, India

Kailash Cancer Hospital & Research Centre; 🇮🇳 Vadodara, GUJARAT, India

Kasturba Medical College Hospital; 🇮🇳 Kannada, KARNATAKA, India

KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

Lokmanya Tilak Munciple Medical College and General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Scroll for more (14 remaining)

Apple Hospital

🇮🇳Surat, GUJARAT, India

Dr Ghanshyam Patel

Principal investigator

9376913131

gnonco@gmail.com