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CTRI Number  CTRI/2021/04/033049 [Registered on: 23/04/2021] Trial Registered Prospectively
Last Modified On: 08/12/2021
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Crossover Trial 
Public Title of Study   A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, crossover, single dose, bioequivalence study of Docetaxel in patients with solid tumours 
Scientific Title of Study   A multicenter, open label, randomized, balanced, two treatment, two period, two sequence, crossover, single dose, bioequivalence study of BH009 [Docetaxel Injection 80 mg/4 mL (20 mg/mL), developed by: Zhuhai Beihai Biotech Co., Ltd.] against Winthrop (docetaxel) injection 20 mg/mL (an authorized generic drug of Taxotere®; manufactured by: Sanofi-Aventis Deutschland GmbH) in patients with solid tumors requiring treatment with docetaxel monotherapy (Dose: 75 mg/m2). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
20-VIN-0225 version 04 dated 03 Mar 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumit Arora 
Designation  Vice President Clinical Operations 
Affiliation  Veeda Clinical Research Pvt, Ltd. 
Address  Veeda Clinical Research Pvt. Ltd Shivalik Plaza, Near I.I.M. Ambawadi Ahmedabad, Gujarat 380 015 India Ahmadabad GUJARAT 380015 India

Ahmadabad
GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Sumit.arora@veedacr.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravi Alamchandani 
Designation  Dy. General Manager  
Affiliation  Veeda Clinical Research Pvt, Ltd. 
Address  Veeda Clinical Research Pvt. Ltd Shivalik Plaza, Near I.I.M. Ambawadi Ahmedabad, Gujarat 380 015 India

Ahmadabad
GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Ravi.A1950@veedacr.com  
 
Details of Contact Person
Public Query  
Name  Dr Ravi Alamchandani 
Designation  Dy. General Manager  
Affiliation  Veeda Clinical Research Pvt, Ltd. 
Address  Veeda Clinical Research Pvt. Ltd Shivalik Plaza, Near I.I.M. Ambawadi Ahmedabad, Gujarat 380 015 India


GUJARAT
380015
India 
Phone  7930013000  
Fax  7930013010  
Email  Ravi.A1950@veedacr.com  
 
Source of Monetary or Material Support  
Zhuhai Beihai Biotech Co., Ltd., Blg 2, No. 6366, Zhuhai Ave., Jinwan, Zhuhai, 519090, China 
 
Primary Sponsor  
Name  Zhuhai Beihai Biotech Co Ltd 
Address  Blg 2, No. 6366, Zhuhai Ave., Jinwan, Zhuhai, 519090, China 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gopichand M  HCG City Cancer center  33-25-33 Ch venkata krishnaya Street suryarao pet Vijaywada 520002 Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH 		 9885256059

mgopichand@yahoo.com 
Dr Rajnish Nagarkar  HCG Manavata Cancer Centre   Clinical Research Department Behind Shivang Auto Mumbai Naka Nashik 422002 Maharashtra India
Nashik
MAHARASHTRA 		 9823061929

drraj@manavatacancercentre.com 
Dr Prakash S S  K.R. Hospital, Mysore Medical College & Research Institute  2nd Floor New Surgical Block Dept. of Surgical Oncology Clinical Research Room Next to NSB 12 Mysore-570001 Karnataka
Bangalore
KARNATAKA 		 9901000559

Prakashyesyes@yahoo.com 
Dr Niraj Bhatt  Kailash cancer Hospital and research center  Clinical Research department Goraj Waghodia Vadodara 391760
Vadodara
GUJARAT 		 2668265396

niraj.bhatt@greenashram.org 
Dr Jayanti G Patel  Nirmal Hospital Pvt. Ltd  Clinical Research department Ring Road Surat 395002 Gujarat India
Surat
GUJARAT 		 8141397388

pateldrjayanti@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
IEC Kailash cancer Hospital and research center  Approved 
IEC, MMC & RIE Associated Hospitals  Approved 
Institutional Ethics Committee HCG Cancer Centre   Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Nirmal Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Docetaxel Injection 80 mg/4 mL, developed by: Zhuhai Beihai Biotech Co. Ltd.  Period I (Day 1): Patients will receive 75 mg/m2 dose of docetaxel injection for intravenous infusion (either test or reference product) on the first day of the chemotherapy cycle. Period II (Day 22): Patients will be crossover to another treatment arm to receive 75 mg/m2 dose of docetaxel injection for intravenous infusion (either test or reference product depending of crossover sequence) on the first day of the next chemotherapy cycle. This will be followed by end of study safety assessment Day 29. hence the study duration will be 29 day for each patient 
Comparator Agent  Winthrop (docetaxel) injection 20 mg/mL (an authorized generic drug of Taxotere®; manufactured by: Sanofi-Aventis Deutschland GmbH)  Period I (Day 1): Patients will receive 75 mg/m2 dose of docetaxel injection for intravenous infusion (either test or reference product) on the first day of the chemotherapy cycle.Period II (Day 22): Patients will be crossover to another treatment arm to receive 75 mg/m2 dose of docetaxel injection for intravenous infusion (either test or reference product depending of crossover sequence) on the first day of the next chemotherapy cycle. This will be followed by end of study safety assessment Day 29. hence the study duration will be 29 day for each patient 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients meeting all of the following criteria will be considered for enrollment in the study.
1. Patients of either gender, more than or equal 18 years of age.
2. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
3. Histologically or cytologically confirmed advanced solid tumors who are scheduled to receive treatment with single-agent docetaxel, in the dose of 75 mg/m2 or those whose are already receiving single-agent docetaxel (taxotere or an approved generic drug of taxotere®), in the dose of 75 mg/m2 and are scheduled to two more cycles, in the same dose, as per the actual treatment plan. Note: Metastatic castration-resistant prostate cancer will not be considered for the study as the patients are required to receive prednisone along with docetaxel and the regime of dexamethasone (CYP 3A4 inducer is different from that in other indications)
4. ECOG performance status 0 or 1 and Life expectancy ≥3 months (as per the Investigator’s discretion).
5. Adequate Hematopoietic, Renal and Liver function defined as the following:
Body system Parameters Bone marrow function
Bone marrow function
ANC more than or equal to 1500/mm3
Platelet count more than or equal to 100,000/mm3
Haemoglobin more than 9.0 g/dl
Hepatic function ALT/AST less than or equal 1.5 × ULN
Alkaline phosphatase less than or equal 2.5 × ULN
Total Bilirubin less than or equal ULN
Renal function Serum creatinine less than or equal 1.5 x ULN
6. Prothrombin time, international normalized ratio or activated partial
thromboplastin time less than 1.5 × ULN; Use of full dose anticoagulants is permitted.
These laboratories should be maintained within the therapeutic range and closely
monitored by the Investigator.
7. Recovery, to Grade 0-1 (as per CTCAE 5.04 criteria), from adverse events
related to prior anticancer therapy except alopecia and endocrinopathies
controlled with hormone replacement therapy.
8. Prior chemotherapy (except ongoing taxotere or an approved generic of taxotere,
in which last dose must have been received at least 21 days prior to cycle 1 of
the study), immunotherapy and radiation therapy must be completed at least 30
days prior to randomization (42 days for mitomycin C or nitrosoureas).
Completion of palliative radiotherapy to a single disease site must be completed
at least 14 days prior to randomization.
9. In case of female patient, the serum pregnancy test at screening visit and urine
pregnancy test at baseline must be negative.
10. Sexually active women, unless surgically sterile (at least 6 months prior to Study
drug administration) or postmenopausal for at least 12 consecutive months, must
use an effective method of avoiding pregnancy (including oral, transdermal, or
implanted contraceptives [any hormonal method in conjunction with a
secondary method], intrauterine device, female condom with spermicide,
diaphragm with spermicide, absolute sexual abstinence, use of condom with
spermicide by sexual partner or sterile [at least 6 months prior to Study drug
administration] sexual partner) for at least 1 month prior to study drug
administration, during study and up to 6 month after the last dose of study drug.
Cessation of birth control after this point should be discussed with a responsible
physician.
 
 
ExclusionCriteria 
Details  Patients will be excluded from the study, if they meet any of the following criteria:
1. Hypersensitivity or idiosyncratic reaction to docetaxel, its excipients, and/or
related substances including polysorbate 80, paclitaxel, alcohol, dexamethasone
and Antiemetic (Granisetron or Ondansetron).
2. Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or
unstable angina within 6 months of study entry; NYHA class III or IV heart
failure within 6 months of study entry; uncontrolled arrhythmia within 6 months
of study entry.
3. Average corrected QT (QTc) interval by Frederica’s formula (QTcF) on
triplicate ECGs at screening > 470 msec (females) or > 450 msec (males); or on
concomitant medications that would prolong the QT interval; or have family
history of long QT syndrome.
4. Patients with an active infection (e.g. tuberculosis, sepsis and opportunistic
infections).
5. Patients with severe pleural effusion (volume involving > 40% of the
hemithorax on CT scan chest) or gross ascites (>800 mL of ascitic fluid)3,4.
6. Peripheral neuropathy ≥grade 2 (as per CTCAE 5.04 criteria).
7. A positive hepatitis screen including hepatitis B surface antigen and HCV
antibodies.
8. Patients with HIV infection.
9. Patients with known brain metastasis or those showing neurologic symptoms
due to brain metastasis.
10. Recent or clinically significant history of drug or alcohol abuse.
11. Patients require concomitant treatment with potent Cytochrome P450 3A4
inhibitors, inducers or substrates.
12. Use of any Cytochrome P450 3A4 inducers, inhibitors, or substrates that may
alter docetaxel metabolism (e.g. dronedarone, epirubicin, sorafenib, CNS
depressants) within 14 days before randomization.
13. Major surgery within 4 weeks prior to study entry; minor surgery within 2
weeks prior to study entry.
14. Patients found positive on urine scan for drugs of abuse and/or breath test for
alcohol consumption at screening or baseline.
Note: Benzodiazepines and /or opioids given in therapeutic doses under the
observation of physician for management of insomnia / anxiety / pain, etc., will
be allowed, provided that there is no drug-drug interaction with the study drug
and an approval from the Veeda medical monitor is taken.
15. The receipt of an investigational medicinal product or participation in other drug
research study within a period of 30 days (or 5 half-lives, whichever is longer)
prior to the first dose of investigational medicinal product for the current study.
16. Pregnant or Breast feeding female.
17. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first
dose of investigational medicinal product for the current study.
18. Abnormal baseline laboratory/physical findings considered to be clinical
significant by the investigator.
19. Patients with any significant history of non-compliance or inability to reliably
grant informed consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate pharmacokinetic and establish the bioequivalence of the test product Docetaxel Injection 80 mg/4 mL) of Zhuhai Beihai Biotech Co., Ltd.,
China relative to that of reference product Winthrop (docetaxel) injection 20
mg/mL (an authorized generic drug of Taxotere®), manufactured by: Sanofi Aventis Deutschland GmbH in patients with solid tumors requiring treatment
with docetaxel monotherapy at a dose of 75 mg/m2 		 Total 17 blood samples for PK assessment will be collected on Day 1 and Day 21.The pre-infusion blood sample of 06 ml will be collected within 5 minutes prior to start of infusion. The blood samples of 06 ml each will be drawn at 0.500(30 min), 0.667(40 min), 0.833(50 min) during infusion, 1 hr (immediately at actual end of infusion), 0.083 (5 min), 0.167 (10 min), 0.333 (20 min), 0.500 (30 min),1.000, 2.000, 3.000, 6.000, 8.000, 12.000, 24.000 and 48.000hrs post infusion. 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability profile of the study formulations.  Physical examination,vital signs,ECG,laboratory evaluations and adverse event monitored at Baseline at screening and 24 hrs prior dosing and 48 hrs post dose. Day 7 safety assessment. On Day 21 at 24 hrs prior dosing and 48 hrs post dose. Day 29 at end of the study vist. For AE will be followed for 30 days or until resolution/ stabilization after last IMP administration. 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="46" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/05/2021 
Date of Study Completion (India) 27/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study will be conducted in patients with solid tumors for whom single-agent docetaxel, in the dose of 75 mg/m2, is a suitable treatment option. Each patient, meeting all the inclusion criteria and none of the exclusion criteria, will receive test or reference product in a cross over manner based on randomization schedule. A balance between T-R and R-T randomization sequence will be ensured using statistical techniques. Blood samples for PK assessment will be collected prior to and after start of intravenous infusion on Day 1 (Period I), Day 22 (Period II).
 
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