Bioequivalence study of Doxorubicin Hydrochloride Liposome Inj(20mg/10mL) administered in female patients with ovarian cancer.

Completed

• Conditions: Ovarian cancer

• Registration Number: CTRI/2018/04/013185
• Lead Sponsor: Mylan Laboratories Limited

Brief Summary

A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, two way crossover, single dose, bioequivalence study of Doxorubicin Hydrochloride  Liposome Injection  (20 mg/10 mL) administered in female patients with ovarian cancer whose disease has progressed or recurred after platinum based chemotherapy under fed condition. The total study duration will be 43 days from the first day of Investigational medicinal product administration. Patients with Ovarian Cancer whose disease has progressed or recurred after Platinum-based chemotherapy and who are already receiving or scheduled to start Doxorubicin Hydrochloride liposomal injection 50 mg/m2 dose as monotherapy will be enrolled in the study. Patients with prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment will be excluded from the study. Total 25 blood samples will be collected during each period. Dr.Aseem kumar Samar(Malpani multispeciality hospital, Jaipur),Dr.Nirmal Raut(Bhaktivedanta hospital & research institute, Thane), Dr.Rakesh Neve(PDEA’s Ayurved Rugnalay & sterling multispeciality hospital, Pune), Dr.Tanveer Maksud (Unique multispeciality hospital, Surat),Dr.Gopichand M(City cancer centre,Vijaywada), Dr.Chinmay Kumar Basu(Netaji subhashchandra bose cancer research institute, Kolkata), Dr.Mukesh Singhal (Acharya Tulsi Regional Cancer centre, Bikaner),Dr.Pramod Patil(Kailash cancer hospital and research centre,Goraj, Vadodara), Dr.Sapna Datta(Surya superspeciality hospital, Varanasi),Dr.Rajeev L K(Shree venketshwar hospital, Banglore), Dr. Rajnish Nagarakar (Curie Manavta Cancer centre, Nashik). Following sites have started enrolling patients. First patient was screened on 1st Jan 2018 and first patient randomized was 17th Jan 2018.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Study Completion: 2019-10-10
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• 1 Non-smoker, female, having a Body Mass Index (BMI) atleast 17 2 Patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start Doxorubicin Hydrochloride liposomal injection.
• 3 Patients with life expectancy of at least 3 months.
• 4 Adequate hemopoeitic, renal and liver function.
• 5 Sexually active women, unless surgically sterile or postmenopausal.

Exclusion Criteria

• 1 History of allergy or hypersensitivity reactions to Doxorubicin Hydrochloride or the components of Doxorubicin Hydrochloride Liposome Injection or any related compound at any dose or other anthracycline drugs, or granisetron or dexamethasone.
• 2 Patients who require a dose reduction to below 50mg/m2.
• 3 Prior history of acute infusion related reaction.
• 4 Prior Doxorubicin exposure that would result in a total lifetime exposure of 550 mg/m2 or more after four cycles of treatment.
• 5 Patient having active opportunistic infection or other clinically significant infection 6 Patients with history of other clinically significant concomitant disease.
• 7 Participation in another clinical trial within 60 days prior to first day of dosing of Investigational Medicinal Product.
• 8 Pregnant or breastfeeding female.
• 9 Patients with any cardiac risks.
• 10 Patients with hepatic impairment and severe renal impairment.
• 11 A positive HIV and hepatitis screen.
• 12 Donation of blood within 90 days prior to receiving the first dose of Investigational Medicinal Product for the current study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
To compare and evaluate the single dose,comparative bioavailability of Doxorubicin Hydrochloride Liposome Inj.(20mg/10mL)	Total 25 blood samples in each period.

Secondary Outcome Measures

Name	Time	Method
To monitor the adverse events and to ensure the safety of patients	Physical examination will be done at screening and during study period.

Trial Locations

Locations (10)

Apple hospital; 🇮🇳 Surat, GUJARAT, India

Government Medical College & Hospital, Dept. of Radiation therapy & oncology; 🇮🇳 Nagpur, MAHARASHTRA, India

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

Meenakshi Mission hospital and reserch centre; 🇮🇳 Madurai, TAMIL NADU, India

MNJ Institute of Oncology & Regional Cancer Centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Sahyadri hospital; 🇮🇳 Pune, MAHARASHTRA, India

Shetty’s Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Shree Giriraj Multi speciality hospital; 🇮🇳 Rajkot, GUJARAT, India

Sparsh Hospital; 🇮🇳 Khordha, ORISSA, India

Srikara Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Apple hospital

🇮🇳Surat, GUJARAT, India

Dr G N Patel

Principal investigator

9376913131

drgnpatelonco@gmail.com