| CTRI Number |
CTRI/2011/12/002266 [Registered on: 21/12/2011] Trial Registered Prospectively |
| Last Modified On: |
25/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to demonstrate bioequivalence between two drugs Xeloda (Reference) and Capecitabine 500 mg Tablets (Test) in cancer patients |
|
Scientific Title of Study
|
A multicentre, randomized, open-label, single dose, two-treatment, three-period, three sequence, partial replicate, crossover, pivotal bioequivalence study of Test capecitabine 500 mg tablets manufactured by Reliance Life Sciences Pvt. Ltd., India with Xeloda® (capecitabine 500 mg) manufactured by Roche Pharma AG, Germany in adult, human, cancer patients under fed condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RC/0111/009, Version No. 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parvez Kosgi |
| Designation |
Head RLS Clinical Trials |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
Reliance Clinical Research Services
Reliance Life Science Pvt. Ltd.
Dhirubhai Ambani Life Sciences Centre
Plot No. R 282 TTC Area of MIDC
Thane Belapur Road Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02267678258 |
| Fax |
02267678222 |
| Email |
Parvez.kosgi@relclin.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ameykumar Mane |
| Designation |
Head Medical Affairs & Pharmacovigilance |
| Affiliation |
Reliance Life Sciences P. Ltd. |
| Address |
Reliance Clinical Research Services,
Reliance Life Sciences Pvt. Ltd.
Dhirubhai Ambani Life Sciences Center
Plot No. R 282 Thane-Belapur Road
Rabale Navi Mumbai India
Thane
MAHARASHTRA
400 701
India |
| Phone |
02267678269 |
| Fax |
02267678222 |
| Email |
Ameykumar_mane@relbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parvez Kosgi |
| Designation |
Head RLS Clinical Trials |
| Affiliation |
Reliance Life Sciences Pvt. Ltd. |
| Address |
Reliance Clinical Research Services
Reliance Life Science Pvt. Ltd.
Dhirubhai Ambani Life Sciences Centre
Plot No. R 282 TTC Area of MIDC
Thane Belapur Road Rabale Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
02267678258 |
| Fax |
02267678222 |
| Email |
Parvez.kosgi@relclin.com |
|
|
Source of Monetary or Material Support
|
| Reliance Life Sciences Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Reliance Life Sciences Pvt Ltd |
| Address |
Dhirubhai Ambani Life Sciences Center,
Plot No. R 282,Thane-Belapur Road,
Rabale, Navi Mumbai-400 701, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Gupte |
Cancer Clinic |
Room No 208 Shreewardhan Complex Wardha Road Nagpur- 440012
Nagpur
MAHARASHTRA |
09373107176
07122444729
smita_gupte@rediffmail.com |
| Dr Praveen Gantawar |
Columbia Hospital and Research Centre |
Room No 3 3rd Floor, Hyatt Medicare
Dhantoli Nagpur 440012
Nagpur
MAHARASHTRA |
09422108822
drpgantawar@gmail.com |
| Dr Rajnish Vasant Nagarkar |
Curie Manavata Cancer Centre |
Curie Manavata Cancer Centre,
Opp Mahamarg Bus Stand,
Mumbai Naka,
Nashik-422001
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Jaiprakash Baraskar |
Dr. Baraskar Hospital and Cancer Care Center |
Room 05 3rd Floor
278 Central Bazaar Road Ramdaspeth Nagpur 440010
Nagpur
MAHARASHTRA |
07122420050
jpcancercare2005@yahoo.co.in |
| Dr Unmesh Takalkar |
Kodlikeri Memorial Hospital |
8 Manjeet Nagar Opp. Akashwani Jalna Road Aurangabad 431005
Aurangabad
MAHARASHTRA |
09822042425
02402335751
Unmesh_3@sancharnet.in |
| Dr Amit Parasnis |
Medipoint Hospitals Pvt. Ltd |
Medipoint Hospitals Pvt. Ltd New DP Road Aundh Pune 411007
Pune
MAHARASHTRA |
02039841200
02040098635
Drrahul.pentagon@gmail.com |
| Dr Kirushna Kumar |
Meenakshi Mission Hospital |
1st Floor Department Of Medical Oncology Lake Area Melur Road Madurai 625 107
Madurai
TAMIL NADU |
09787713004
drkskk@yahoo.com |
| Dr Bharath Rangarajan |
Narayana Hrudayalaya Hospital |
7th Floor 258/A Bommasandra Industrial Area Anekal Taluk Bangalore 560 099
Bangalore
KARNATAKA |
08027835315
bharath37@gmail.com |
| Dr Minish Jain |
Ruby Hall Clinic |
40 Sassoon Road
Pune 411 001
Pune
MAHARASHTRA |
9823133390
minishjain009@gmail.com |
| Dr Shailesh Bondarde |
Shatabdi Super Specialty Hospital |
Opposite Mahamarg Bus Stand Mumbai Naka Nasik 422 005
Nashik
MAHARASHTRA |
0253-25008888
shaileshbondarde@yahoo.com |
| Dr Nirmal Raut |
Sterling Wockhardt Hospital |
Room No 104 Ground Floor On Sion Panvel Expressway Sector 7 Vashi, Navi Mumbai 400703 India
Thane
MAHARASHTRA |
09930398156
02266804444
drnirmalraut@gmail.com |
| Dr Vikram Gota |
Tata Memorial Centre |
ACTREC Sector 22 Kharghar
Navi Mumbai 410210
Mumbai (Suburban)
MAHARASHTRA |
02227405130
02227405061
vgota@actrec.gov.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethical Review Board, Meenakshi Mission Hospital & Research Center, Madurai |
Approved |
| Ethics Committee, Kodlikeri Memorial Hospital & CIIGMA Hospital , Aurangabad |
Approved |
| Ethics RUs, Mumbai |
Approved |
| Global Health Concern Ethics Committee, Nagpur |
Approved |
| Human Ethics Committee, Tata Memorial Centre (HEC, TMC) |
Submittted/Under Review |
| MCRI Professional Ethics Committee |
Submittted/Under Review |
| Nagpur Independent Ethics Committee |
Approved |
| Nagpur Independent Ethics Committee, Nagpur |
Approved |
| Narayana Hrudayalaya Medical Ethics Committee, Bangalore |
Approved |
| Penta-Med Ethics Committee, Pune |
Approved |
| Poona Medical Research Foundation |
Approved |
| Shatabdi Super Specialty Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Locally advanced or metastatic breast cancer or metastatic colorectal cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Capecitabine (Xeloda) Tablets |
Dose & Frequency: 500 mg per day
Duration: 3 days (D1, D3, D5)
Mode of Administration: Oral
|
| Intervention |
Capecitabine Tablets
|
Dose & Frequency: 500 mg per day
Duration: 3 days (D1, D3, D5)
Mode of Administration: Oral
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Males or females 18 to 70 years of age.
Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
Patients with histopathologically/ cytologically confirmed breast cancer or colorectal cancer.
Cancer patients who are already receiving stable twice daily dosing regimen of capecitabine as prescribed by treating physician.
Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Patients with life expectancy of at least 3 months.
Patients should be non-smokers.
Patients willing to voluntarily provide written informed consent or consent from a Legally Acceptable Representative (LAR), if the patient is not in a condition to give consent.
|
|
| ExclusionCriteria |
| Details |
Patients with inadequate venous access to allow the collection of all samples via venous cannula in the study.
Pregnant (female patients with a positive urine pregnancy test at screening and positive serum pregnancy test before period I of hospitalization) or lactating females.
Patients with the following abnormal laboratory parameters:
a. Serum creatinine more than 2.0 times of upper normal limit
b. Aspartate amino transferase (AST) or alanine amino transferase (ALT) more than 2.5 times of upper normal limit
c. Alkaline phosphatase ≥ 1.5 times of upper normal limit
d. Platelet count les than 100,000/μL.
e. Hemoglobin less than 8.0 g/dL.
f. Absolute Neutrophil Count (ANC) less than 1.5 x 10 to power 9 /L.
Patients with a known hypersensitivity to fluoropyrimidine therapy or known sensitivity to 5- fluorouracil or known Dihydropyrimidine dehydrogenase (DPD) deficiency.
Patients with known brain metastasis and/or pre-existing motor or sensory neurotoxicity of severity ≥2 by National; Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) criteria.
History or evidence of uncontrolled coagulopathy.
History of hereditary galactose/ glucose/ lactase disorders.
History or evidence of cardiac disease (Myocardial Infarction in last 6 months, unstable angina, heart failure, uncontrolled ventricular arrhythmia, significant pericardial disease).
Patients with a history of alcoholism, found with current alcohol abuse based on Alcohol breath test and/ or drug abuse or who test positive in the urinary screening for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) except as required as medication for the current medical condition.
Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
Patients having an abnormal serum calcium level at screening visit which as judged by the investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
Patients who have participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months.
Any other condition which the investigator feels would pose a significant hazard to the patient if IP is administered.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Establish the bioequivalence of Test vs Reference in relation to the rate and extent of absorption on the basis of the following pharmacokinetic parameters:
• Cmax
• AUC0—t |
• D1, D3, D5
• D1, D3, D5
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor adverse events, including laboratory parameters |
D1, D3, D5, D6 |
To determine other pharmacokinetic parameters of Test and Reference products.
• Tmax
• AUC0-∞
• Kel
• t1/2 |
D1, D3, D5
D1, D3, D5
D1, D3, D5
D1, D3, D5 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/02/2012 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open-label, single-dose, two-treatment, three-sequence, three-period, partial replicate, crossover, comparative bioequivalence study. Trial comparing bioequivalence of Xeloda 500 mg and Capacitabine 500 mg in 66 patients of locally advanced or metastatic breast cancer or metastatic colorectal cancer. |