Belgaum Cancer Hospital, 9666-A2/D, Ashok Nagar, Belgaum- 590016, Karnataka, India Belgaum KARNATAKA
9844033384
bch_belgaum@rediffmail.com
Dr VSatya Suresh Attili
BIBI General Hospital & Cancer Centre
BIBI General Hospital & Cancer Centre, 16-3-991/1/C, Government Printing Press Road, Malakpet, Hyderabad-500024, Andhra Pradesh, India Hyderabad ANDHRA PRADESH
9246243034
sureshattili@yahoo.com
Dr Rakesh Taran
CHL-Apollo Hospitals
Dept. of Medical Oncology CHL-Hospital, Near LIG triangle, A.B.Road,Indore-452 008 Indore MADHYA PRADESH
9009779517
rakeshtaran@yahoo.com
Dr Gopichand
City cancer centre
City cancer centre, #33-25-33, Ch. Venkata Krishnayya street,
Suryaro pet, Vijaywada,Andhrapradesh-520 002 Krishna ANDHRA PRADESH
9885256059
mgopichand@yahoo.com
Dr Shailesh Shende
Deenanath Mangeshkar Hospital and Research Centre
Deenanath Mangeshkar Hospital and Research Centre, Erandwane, Pune-411044, Maharashtra, India Pune MAHARASHTRA
9890609830
shaileshshende@rediffmail.com
Dr Kartar Singh
Green City Hospital
Green City Hospital, Near Dhantoli Police Station, Mehadia Square, Dhantoli, Nagpur-440012 Nagpur MAHARASHTRA
9890354174
drkartarsingh@yahoo.com
Dr S P Shrivastav
Lions Cancer Detection Centre
Lions Cancer Detection Centre, New Civil Hospital Campus,
Majura Gate, Surat – 395001, Gujarat, India
Surat GUJARAT
9824196710
liononco@gmail.com
Dr Rajeev AG
M.S.Ramaiah medical college and Hospital
Dept. of Radiation Oncology
M.S.Ramaiah medical college and hospital, MSRIT Post, New BEL Road, Bangalore - 560 054. Bangalore KARNATAKA
9844345999
drrajeevag@yahoo.com
Dr Kirushna Kumar
Meenakshi mission hospital and research centre
Dept. of Radiation Oncology
Meenakshi Mission Hospital and Research Centre, Lake Area, Melur Road, Madurai- 625 107. Madurai TAMIL NADU
9842113003
drkskk@yahoo.com
Dr J K Singh
S S Hospital
Dept. of Radiation Oncology S S Hospital, Malahi Pakri Chowk, Doctors Colony, Kankarbagh, Patna- 800020. Patna BIHAR
9006330804
drjksingh147@hotmail.com
Dr Tushar Patil
Sahyadri Speciality Hospital
Dept. of Medical Oncology Sahyadri Speciality Hospital, Eraldwane, Karve Road, Pune-411004 Pune MAHARASHTRA
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
TEMODAL ® 250 mg capsules
One capsule of 250 mg of Temozolomide (Test or Reference) will be administered to the patients in each period. Theperiod I and period II will be the day 1 and day 2 of the treatment cycle.Temozolomide would be provided for the remaining doses of the cycle and remaining cycles to the patients as per PI’s discretion
Intervention
Temozolomide capsule 250 mg
One capsule of 250 mg of Temozolomide (Test or Reference) will be administered to the patients in each period. The period I and period II will be the day 1 and day 2 of the treatment cycle. Temozolomide would be provided for the remaining doses of the cycle and remaining cycles to the patients as per PI’s discretion.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1.Signed written informed consent for participation in the trial. 2. Recovered from any toxic effects of previous chemotherapy as judged by the Investigator.3. Having a Body Mass Index (BMI) at least 17 calculated as weight in kg/height in m2. 4. Patients with a life expectancy of at least three months. 5. Patient with adequate bone marrow, renal and hepatic function. 6. Able to comply with study requirement in opinion of Principal Investigator
ExclusionCriteria
Details
1.Known hypersensitivity to Temozolomide, Dacarbazine or any other ingredients of the formulation
2.Use of any chemotherapy drugs within 21 days prior to dosing
3.History of drug/alcohol addiction
4.History of smoking or tobacco chewing in last 3 months
5.Known Galactose intolerant, known deficiency of the Lapp lactase or glucose-galactose malabsorption
6.A positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies or positive VDRL test
7.Patients with HIV infection.
8.Positive for Drug of abuse test and alcohol screen test
9.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.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To characterize the pharmacokinetic profile of the sponsor’s test formulation (Temozolomide 250 mg capsules) relative to that of reference formulation
(TEMODAL® 250 mg capsules) in adult, male or female, patients under fasting conditions and to assess the bioequivalence
The venous blood samples will be withdrawn Pre-dose and 0.16 (10 min), 0.25
(15 min), 0.33 (20 min) 0.50 (30 min), 0.75 (45 min), 1.00, 1.25, 1.50, 2.00, 2.50,3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each period
administration.
Secondary Outcome
Outcome
TimePoints
To monitor the safety of the patients exposed to the Investigational Medicinal Product
NIL
Target Sample Size
Total Sample Size="40" Sample Size from India="40" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Temozolomide is an
imidazotetrazine-alkylating agent with antitumor activity. At physiological
pH the drug get metabolized to monomethyl triazeno imidazole carboxamide
(MTIC). MTIC shows cytotoxicity due to alkylation at the O6 position of
guanine with additional alkylation also occurring at the N7 position.
This study is being conducted to
compare & characterize the relative bioavailability & pharmacokinetic
profile of the Sponsor’s formulation (Temozolomide capsule 250 mg) with
respect to the reference formulation (Temodal® (Temozolomide) capsules 250
mg) in single oral dose to adult patients with Glioblastoma Multiforme or
Anaplastic Astrocytoma under fasting condition,who in the opinion of their
treating physicians are candidates for the Temozolomide therapy.
Temozolomide is a cytotoxic drug;
hence the study cannot be conducted on the healthy volunteer.
The primary objective of the study
is to characterize the pharmacokinetic profile of the sponsor’s test
formulation to that of reference formulation & secondary objective is to
monitor the safety of the patients.
Bioequivalence will be concluded if
the 90% confidence intervals for ln-transformed pharmacokinetic parameters Cmax
and AUC0-t fall within the acceptance range of 0.8 – 1.25 for Temozolomide.