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CTRI Number  CTRI/2020/05/025245 [Registered on: 19/05/2020] Trial Registered Prospectively
Last Modified On: 12/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Bioequivalence study of doxorubicin hydrochloride liposome injection 2mg/mL in ovarian cancer subjects under fasting conditions. 
Scientific Title of Study   An open label, multi-center, randomized, two-treatment, two-period, two-sequence, two-way cross-over, single dose bioequivalence study of doxorubicin hydrochloride liposome injection 2mg/mL for intravenous infusion 50mg/m2 of shanghai jingfeng pharmaceuticals group co., ltd., china with DOXOrubicin hydrochloride liposome injection 2mg/mL for intravenous infusion 50mg/m2 of sun pharmaceuticals ind. ltd. in ovarian cancer subjects whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy on doxorubicin hydrochloride (liposomal) under fasting conditions. 
Trial Acronym  CBCC/2019/019, Version 2.0 dated 09/Mar/2020. 
Secondary IDs if Any  
Secondary ID  Identifier 
CBCC/2019/019, Version 2.0 dated 09/Mar/2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House, Opposite L. J Campus, S. G. Highway, Sarkhej, Ahmedabad – 382210, India.

Ahmadabad
GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House, Opposite L. J Campus, S. G. Highway, Sarkhej, Ahmedabad – 382210, India.


GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Singh 
Designation  Director Operations 
Affiliation  CBCC Global Research LLP 
Address  Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House, Opposite L. J Campus, S. G. Highway, Sarkhej, Ahmedabad – 382210, India.


GUJARAT
382210
India 
Phone  9637555304  
Fax  9726434204  
Email  sandeep.singh@cbccusa.com  
 
Source of Monetary or Material Support  
Shanghai Jingfeng Pharmaceuticals Group Co., Ltd., China 
 
Primary Sponsor  
Name  Shanghai Jingfeng Pharmaceuticals Group Co Ltd China  
Address  50 Luoxin Rd., Baoshan District Shanghai 201908, China 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajnish Nagarkar  HCG Manavata Cancer Centre  1st Floor, MCRI Department, Behind Shivang Auto, Mumbai Naka, Nashik - 422001, Maharashtra, India.
Nashik
MAHARASHTRA 
9823061929

drraj@manavatacancercentre.com 
Dr Ravikumar Narayan Wategaonkar  Lokmanya Holistic Cancer Care and Research Centre  3rd Floor, Clinical Research Department, Chinchwad Station Rd, Sudarshan Nagar, Pune, Maharashtra-411033, India.
Pune
MAHARASHTRA 
8828017488

rnwategaonkar@gmail.com 
Dr Prakash Kuppa  MNJ Institute of Oncology & Regional Cancer Center  3rd Floor, Red Hills, Hyderabad-500004, Telangana, India.
Hyderabad
TELANGANA 
9849167371

drprakashmnj@gmail.com 
Dr Chinmay Kumar Basu  Netaji Subhash Chandra Bose Cancer Hospital  2nd Floor, 3081, Nayabad Main Rd, New Garia, Pancha Sayar, Kolkata,-700094, West Bengal, India.
Kolkata
WEST BENGAL 
9830114880

nscbcri2017@gmail.com 
Dr Ghanashyam Biswas  Sparsh Hospital and Critical Care  Ground Floor, A/407, Back Side of Kalyan Jewellers, Saheed Nagar, Bhubaneswar -751007, Odisha, India.
Bhadrak
ORISSA 
9937500878

drgbiswas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee, N S C B C Research Institute  Submittted/Under Review 
Lokmanya Medical Research Centre  Submittted/Under Review 
Manavata Clinical Research Institute Ethics Committee  Approved 
MNJ Institute of Oncology and Regional Cancer Centre  Submittted/Under Review 
Sparsh Hospital and Critical Care  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Doxorubicin hydrochloride liposome injection 2mg/mL for intravenous infusion 50mg/m2 of shanghai jingfeng pharmaceuticals group co., ltd., china.  The investigational product will be administered to each subject on Day 1 (Period 01) and Day 29 (Period 02) at a dose of 50mg/m2 as intravenous infusion via infusion pump over 60 minutes period (±5 minutes) as per the randomization schedule. 
Comparator Agent  DOXOrubicin hydrochloride liposome injection 2mg/mL for intravenous infusion 50mg/m2 of sun pharmaceuticals India ltd.  The investigational product will be administered to each subject on Day 1 (Period 01) and Day 29 (Period 02) at a dose of 50mg/m2 as intravenous infusion via infusion pump over 60 minutes period (±5 minutes) as per the randomization schedule 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  1. Willing and able to provide voluntary informed consent and to follow the protocol requirements
2. Female subjects between 18 and 75 years of age, both inclusive and having Body mass index BMI more than or equal to 17.00 calculated as weight in kg Per height in m2
3. Histopathologically confirmed ovarian cancer
4. Documented progressive or recurrent disease after treatment with platinum based chemotherapy
5. Able and clinically indicated to receive the recommended minimum 2 cycles of liposomal doxorubicin HCl
6. Eastern Cooperative Oncology Group ECOG performance status of less than or equal to 2
7. Life expectancy of more than 180 days at the time of enrollment
8. Acceptable hematology status
a. Hemoglobin more than or equal to 9 g Per dL
b. Absolute neutrophil count ANC more than or equal to 1500 cells Per Microlitre
c. Platelet count more than or equal to 1,00,000 cells Per Microlitre
9. Acceptable liver function
a. Alanine aminotransferase (ALT) less than or equal to 2X upper limit of normal ULN
b. Aspartate aminotransferase (AST) less than or equal to 2X ULN
c. Bilirubin less than 1.2 mg Per dL
d. Alkaline phosphatase less than or equal to 2.0 X ULN
10. Subjects with creatinine clearance more than or equal to 60 mL per minute.
11. Cardiac ejection fraction more than or equal to 50 percent by echocardiogram ECHO within 14 days prior to first dose of Investigational Product
12. Subjects with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0
13. Women of child bearing potential, defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product practicing two acceptable methods of contraception
Acceptable methods of contraception are
A. Intrauterine device IUD or intrauterine system IUD or IUS
B. Double barrier method of contraception (Condom and occlusive cap or condom and spermicidal agent)
C. Male sterilization at least 6 months prior to the screening, should be the sole male partner for that subject
D. Female sterilization surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
E. Total abstinence, partial abstinence is not acceptable
14. No history of addiction to any recreational drug or drug dependence or alcohol addiction
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity or contraindication including anaphylaxis to conventional or liposomal formulations of doxorubicin, anthracycline therapy or to any of their components.

2. Subjects with prior doxorubicin exposure that would result in a total lifetime exposure of 550mg/m2 or more after four cycles of treatment

3. Received previous chemotherapy less than 4 weeks prior to dosing of Investigational Product.

4. Recent (6 month) history of myocardial infarction or severe arrhythmias prior to dosing of Investigational Product.

5. Received any prior mediastinal irradiation (as cardiac toxicity may occur at cumulative doses lower than 400mg/m2).

6. Receipt of trastuzumab within 24 weeks prior to dosing of Investigational Product and during the study.

7. Receipt of cyclophosphamide, calcium channel blockers, and other potential cardiotoxic drugs for 2 weeks prior to dosing of Investigational Product, and during the study.

8. Subjects taking inducers and inhibitors of CYP3A4, CYP2D6 or P-gp
9. Pregnant or lactating women.
10. History or presence of any uncontrolled debilitating systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.)
11. Active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganism if under treatment with myelotoxic drugs.

12. Known central nervous system metastasis.

13. Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.

14. Surgical or other non-healing wounds.
15. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
16. History of other malignancies in the last 5 years. (except in situ cancer or basal or squamous cell skin cancer)

17. Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), Hemoglobin more than or equal to 9.0 g/dL, fatigue (Grade 2 is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).

18. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.

19. Participation in any clinical study within 90 days before the first dose of Investigational Product.

20. Donation and/or loss of more than or equal to 350 ml (1 unit) of blood within 90 days before the first dose of Investigational Product.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the bioequivalence of doxorubicin hydrochloride liposome injection 2mg/mL of shanghai jingfeng pharmaceuticals group co., ltd., china with DOXOrubicin hydrochloride liposome injection 2mg/mL for intravenous infusion of sun pharmaceuticals ind. ltd. in ovarian cancer subjects whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy on doxorubicin hydrochloride (liposomal) under fasting conditions.  A total of 19 PK blood samples will be collected in each period of the study. The sample will be collected on day 0, 1, 2, 3, 5, 8, 11 and 15 in period 01 and on day 28, 29, 30, 31, 33, 36, 39 and 43 in period 02 and during end of study.  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety of subjects.  Safety assessment will be carried out during screening, on day 0, 1, 2, 3, 5, 8, 11 and 15 in period 01 and on day 28, 29, 30, 31, 33, 36, 39 and 43 in period 02 and during end of study. 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The study is An open label, multi-center, randomized, two-treatment, two-period, two-sequence, two-way cross-over, single dose bioequivalence study of doxorubicin hydrochloride liposome injection 2mg/mL for intravenous infusion 50mg/m2 of shanghai jingfeng pharmaceuticals group co., ltd., china with DOXOrubicin hydrochloride liposome injection 2mg/mL for intravenous infusion 50mg/m2 of sun pharmaceuticals ind. ltd. in ovarian cancer subjects whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy on doxorubicin hydrochloride (liposomal) under fasting conditions.

 

The primary Objective of study is to assess the bioequivalence of doxorubicin hydrochloride liposome injection 2mg/mL of shanghai jingfeng pharmaceuticals group co., ltd., china with DOXOrubicin hydrochloride liposome injection 2mg/mL for intravenous infusion of sun pharmaceuticals ind. ltd. in ovarian cancer subjects whose disease has progressed or recurred after platinum-based chemotherapy and who are already receiving or scheduled to start therapy on doxorubicin hydrochloride (liposomal) under fasting conditions

 

The 90% confidence interval of the relative mean (Geometric mean) of the test to reference formulation for Ln-transformed Cmax, AUC0-t and AUC0-inf should be within 80.00% to 125.00% for Free doxorubicin and liposome encapsulated doxorubicin to establish bioequivalence

 
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