| CTRI Number |
CTRI/2011/12/002274 [Registered on: 22/12/2011] Trial Registered Prospectively |
| Last Modified On: |
25/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Clinical trial to compare two drugs, Temodal and Temozolomide 250 mg capsules in cancer patients |
|
Scientific Title of Study
|
A multicentre, randomized, open-label, single dose, two treatment, two period, two sequence, crossover, pivotal bioequivalence study of Test Temozolomide 250 mg capsule manufactured by Reliance Life Sciences Pvt. Ltd., India with Reference Temodal 250 mg capsule of Schering- Plough Ltd, UK in adult, male and/or female cancer patients under fasting conditions. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RC/0111/011, Version No.01, Version date 12/04/2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parvez Kosgi |
| Designation |
Head- RLS Clinical Operation |
| Affiliation |
Reliance Life Sciences Pvt Ltd |
| Address |
Reliance Life Science Pvt Ltd
Reliance Clinical Research Services
Dhirubhai Ambani Life Sciences Centre
Plot No R-282 TTC Area of MIDC
Thane Belapur Road Rabale Navi Mumbai
Thane
MAHARASHTRA
400 701
India |
| Phone |
02267678258 |
| Fax |
02267678299 |
| Email |
parvez.kosgi@relclin.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ameykumar Mane |
| Designation |
Medical Writing & Medical Affairs |
| Affiliation |
Reliance Life Sciences Pvt Ltd |
| Address |
Reliance Life Sciences Pvt Ltd
Reliance Clinical Research Services
Dhirubhai Ambani Life Sciences Center
Plot no R-282 Thane Belapur Road
Rabale Navi Mumbai
Thane
MAHARASHTRA
400 701
India |
| Phone |
02267678269 |
| Fax |
02267678299 |
| Email |
Ameykumar_mane@relbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parvez Kosgi |
| Designation |
Head- RLS Clinical Operation |
| Affiliation |
Reliance Life Sciences Pvt Ltd |
| Address |
Reliance Life Science Pvt Ltd
Reliance Clinical Research Services
Dhirubhai Ambani Life Sciences Centre
Plot No R-282 TTC Area of MIDC
Thane Belapur Road Rabale Navi Mumbai
Thane
MAHARASHTRA
400 701
India |
| Phone |
02267678258 |
| Fax |
02267678299 |
| 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 |
Reliance Life Sciences Pvt Ltd
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 208 |
Room No-208 Shreewardhan Complex Wardha Road Nagpur- 440012 Maharashtra India.
Nagpur
MAHARASHTRA |
9373107176
0712-2444729
smita_gupte@rediffmail.com |
| DrRajnishVasantNagarkar |
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 Maharashtra India
Nagpur
MAHARASHTRA |
9422108822
0712-2452105
jpcancercare2005@yahoo.co.in |
| Dr Srinivasan |
Kamakshi Memorial Hospital |
First Floor No.1 Radial Road Pallikarnai Chennai – 600100 Tamilnadu India
Chennai
TAMIL NADU |
9841022366
drvsreenee71@yahoo.co.in |
| Dr Rajeev |
M.S. Ramaiah Memorial Hospital |
Room No 10 Ground Floor New B E L Road M S Ramaiah Nagar MSRIT Post
Bangalore - 560 054 India
Bangalore
KARNATAKA |
09844345999
080-40528402
drrajeevag@yahoo.com |
| Dr Amit Parasnis |
Medipoint Hospitals Pvt. Ltd |
Room No - 241 1st Floor
New DP Road Aundh Pune-411007
Pune
MAHARASHTRA |
9822601479
amitparasnis@gmail.com |
| Dr Kirushna Kumar |
Meenakshi mission hospital |
1st Floor Department Of Medical Oncology Lake Area Melur Road Madurai- 625 107. Tamil Nadu, India
Chennai
TAMIL NADU |
9787713004
0452-2586353
drkskk@yahoo.com |
| Dr Bharath R |
Narayana Hrudayalaya Hospital |
7th Floor No. 258/A, Bommasandra Industrial Area Anekal Taluk Bangalore 560 099
Bangalore
KARNATAKA |
09591970742
080-27832648
bharat37@gmail.com |
| Dr Minish Jain |
Ruby Hall Clinic |
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA |
9823133390
minishjain009@gmail.com |
| Dr Shailesh Bondarde |
Shatabdi Super Specialty Hospital |
Opposite Mahamarg Bus Stand Mumbai Naka Nasik 422 005 Maharashtra India
Nashik
MAHARASHTRA |
0253-25008888
shaileshbondarde@yahoo.com |
| Dr Nirmal Raut |
Sterling Wockhardt |
Room No 104 Ground Floor On Sion Panvel Expressway Sector 7 Vashi Navi Mumbai 400703 India
Thane
MAHARASHTRA |
09930398156
drnirmalraut@gmail.com |
| Dr Vikram Gota |
Tata Memorial Centre |
ACTREC Sector 22
Kharghar
Navi Mumbai 410210
Mumbai (Suburban)
MAHARASHTRA |
02227405130
vgota@actrec.gov.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Ethical Review Board Bangalore |
Approved |
| Ethical Review Board Meenakshi Mission Hospital & Research Center Madurai |
Approved |
| Ethics RUs Mumbai |
Approved |
| Global Health Concern Ethics Committee Nagpur |
Approved |
| Humabn Ethics Committee |
Submittted/Under Review |
| MCRI Professional Ethics Committee |
Submittted/Under Review |
| Medical Ethics Committee Chennai |
Approved |
| Nagpur Independence 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 |
Glioblastoma Multiforme or Anaplastic Astrocytoma , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Temodal (Schering- Plough Ltd, UK) |
Dose: 250 mg OD
Duration & Frequency: Single dose either on Day 1 or Day 2
Mode of administration. Oral route
|
| Intervention |
Temozolomide (Reliance Life Sciences Pvt. Ltd.)
|
Dose: 250 mg OD
Duration & Frequency: Single dose either on Day 1 or Day 2
Mode of administration. Oral route
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male or female 18 to 70 years of age.
Patients with Body Mass Index (BMI) between 17 kg/m2 and 30 kg/m2.
Cancer patients (glioblastoma multiforme or anaplastic astrocytoma) who are already receiving or are about to start receiving temozolomide 250 mg once daily as their calculated individualized dose (e.g. based upon factors such as tumor type, body surface area, cycle number and toxicity).
Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
Patients with Karnofsky Performance Status of at least 70%.
Patients with life expectancy of atleast 3 months.
Patients should be non-smokers.
Patients willing to voluntarily provide written informed consent or consent from Legally
Acceptable Representative (LAR), if subject is not in the 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 subjects with a positive serum pregnancy test at screening and positive urine pregnancy test before check-in in period I) or lactating females.
Patients with abnormal laboratory parameters like:
a. Serum creatinine greater than 2.0 times of upper normal limit
b. AST or ALT greater than 2.5 times of upper normal limit
c. Alkaline phosphatase ≥1.5 times of upper normal limit
d. Platelet count less than 100,000/μL.
e. Hemoglobin less than 8.0 g/dL.
f. Total WBC Count less than 4000 /µL
g. ANC value less than 1500 /µL
Seizure symptoms, which significantly interfere with normal life and restrict medical treatments that are necessary for patient care.
Patients with chemotherapy or biologic anticancer therapy within 4 weeks before study or nitrosourea therapy within 6 weeks before study entry.
Patients planned or currently receiving focal radiotherapy.
Patients with a known history of drug hypersensitivity to temozolomide or any of the excipients of the formulations.
Patients with known hypersensitivity to dacarbazine (DTIC).
Patients with known history of galactose intolerance or glucose-galactose malabsorption.
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 alcohol, found with current alcohol abuse based on Alcohol breath test and/ or drug abuse or who are found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) except required as medication for current medical condition.
Patients diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
Patients receiving sodium valproate
Patients who participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months.
History or evidence of clinically significant systemic disease or any other condition which investigator feels would pose a significant hazard to patients if IP is administered.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To 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 |
• Cmax: Day 1, Day 2
• AUC0--t: Day 1, Day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To monitor all the adverse events, including laboratory parameters
2. To determine other pharmacokinetic parameters of Test and Reference products.
• Tmax
• AUC0-∞
• Kel
• t1/2
|
1.Adverse events including laboratory parameters :
Day 1, Day 2, Day 3
2. Pharmacokinetic parameters of Test and Reference products.
• Tmax : Day 1, Day 2
• AUC0-∞ : Day 1, Day 2
• Kel : Day 1, Day 2
• t1/2 : Day 1, Day 2
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
15/01/2012 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a multicentre, randomized, open-label, single dose, two-treatment, two period, two sequence, crossover, pivotal bioequivalence study of Test Temozolomide 250 mg capsule manufactured by Reliance Life Sciences Pvt. Ltd., India with Reference Temodal 250 mg capsule of Schering- Plough Ltd, UK in adult, male and/or female cancer patients under fasting conditions. |