CTRI/2021/04/032776 [Registered on: 13/04/2021] Trial Registered Prospectively
Last Modified On:
16/11/2021
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A study of Temozolomide Powder For Oral Suspension in Cancer Patients
Scientific Title of Study
A Multicentre, Open Label, Balanced, Randomized, Single-Dose, Two-Stage, Two-Treatment, Two-Period, Two-Sequence, Two-Way, Cross-Over Study To Evaluate Comparative Bioavailability Of Temozolomide Powder For Oral Suspension, 300 Mg/15 Ml (Test Drug) With Temodal® Capsules 250 mg (Reference Drug) In Patients Of Malignant Gliomas Under- Going Treatment With Temozolomide Under Fasting Conditions.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
0627-19 Version: 1.0 Date: 07 Apr 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Prashant Modi
Designation
Sr. General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department of Project Management & Regulatory
Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G.
Highway,Gota
Ahmadabad GUJARAT 382481 India
Phone
07940202375
Fax
07940202021
Email
prashantmodi@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Naman Shah
Designation
General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department of CTM Medical Services, Plot No. 38,
Survey No. 388 Near Silver Oak Club, S. G. Highway,Gota
Ahmadabad GUJARAT 382481 India
Phone
07940202389
Fax
07940202021
Email
namanshah@lambda-cro.com
Details of Contact Person Public Query
Name
Prashant Modi
Designation
Sr. General Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department of Project Management & Regulatory
Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G.
Highway,Gota
Ahmadabad GUJARAT 382481 India
Phone
07940202375
Fax
07940202021
Email
prashantmodi@lambda-cro.com
Source of Monetary or Material Support
Intas Pharmaceuticals Ltd.,
Corporate House, Nr. Sola
Bridge,
S.G. Highway, Thaltej,
Ahmedabad – 380054
Gujarat, India
Primary Sponsor
Name
Intas Pharmaceuticals Ltd
Address
Corporate House, Nr. Sola
Bridge,
S.G. Highway, Thaltej,
Ahmedabad – 380054
Gujarat, India
Department of Clinical Research, Room No.1/393, Velavan Nagar, Perundurai Road, Thindal, Erode - 638012, Tamil Nadu. Erode TAMIL NADU
9842334222
kvels@rediffmail.com
Dr Rajnish Nagarkar
HCG Manavata Cancer Centre
Department of Clinical Research, Room No.NA, Behind Shivang Auto, Mumbai Naka, Nashik - 422002, Maharashtra. Nashik MAHARASHTRA
9823061929
drraj@manavatacancercentre.com
Dr S P Shrivastav
Kiran Hospital Multi Super Speciality Hospital & Research Centre
Department of Clinical Research, Room No. NA,Near Sumul Dairy, Surat, Gujarat - 395004. Surat GUJARAT
98241967110
communication@kiranhospital.com
Dr Rohan Bhise
KLES Dr. Prabhakar Kore Hospital
Department of Clinical Research, Room No. NA, KLES Dr. Prabhakar Kore Hospital & M.R.C, Nehrunagar-590010 Belgaum KARNATAKA
7975558921
rohanbhise30@gmail.com
Dr Ghanshyam Patel
Nirmal Hospital Pvt Ltd
Nirmal Hospital, Sagrampura, Ring Road 395002 Surat GUJARAT
9376913131
drgnpatelonco@gmail.com
Dr Srinivasan krishnan
Srinivasan Rajalakshmi Memorial Hospital
Department of Clinical Research, Room No. NA, Srinivasan Rajalakshmi Memorial Hospital,No-11/77 ,6th street ,Voltas Colony ,Nanganallur-600061 Chennai TAMIL NADU
9444896010
krishnan_dr@yahoo.com
Dr Rajendra Singh Arora
Sujan Surgical Cancer Hospital & Amravati Cancer Foundation
Department of Clinical Research, Room No. NA, Sujan Surgical Cancer Hospital & Amravati Cancer Foundation52/b Shankar Nagar Main Road,
Amravati-444601 Amravati MAHARASHTRA
9823097573
dr-rsarora@rediffmail.com
Dr Ankit B Patel
Unique Hospital Multispeciality and Research Institute
Department of Clinical Research, Room No. NA, Civil Hospital-Char Rasta Sosyo Circle Canal Road, opp. Kiran Motor- 395002
Surat GUJARAT
9825404202
drankitoncologist@gmail.com
Dr Shashidhar V Karpurmath
Vydehi Institute of Medical Sciences & Research Centre
Department of Clinical Research, Room No.#82, E.P.I.P area, Whitefield, Bangalore - 560066. Bangalore KARNATAKA
Ethics Committee Unique Hospital Multispeciality and Research Institute, Dr Ankit Patel
Approved
Institutiomnal Ethics Committee - Erode Cancer Centre, Dr K Velavan
Approved
Institutional Ethics Committee - Vydehi Institute of Medical Sciences & Research Centre,Dr. Shashidhar V. Karpurmath
Approved
Institutional Ethics Committee of KLE Academy of higher education and research, Dr. Rohan Bhise
Approved
Kiran Hospital Ethics Committee,Dr. S. P. Shrivastav
Approved
Manavata Clinical Research Institute Ethics Committee,Dr Rajnish Nagarkar
Approved
Nirmal Hospital Pvt Ltd,Ethics Commiittee, Dr Ghanshyam Patel
Approved
Srinivasan Rajalakshmi Memorial Institutional Ethics Committee, Dr. Srinivasan krishnan
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: C729||Malignant neoplasm of central nervous system, unspecified,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Temodal® (Temozolomide) capsule 250 mg
Dose: 250 mg;
Duration of therapy and frequency: Single dose;
Pharmaceutical form: Capsule;
Route of administration: Oral
Intervention
Temozolomide oral Suspension 300 mg/15 ml
Dose: 250 mg;
Duration of therapy and Frequency: Single dose;
Pharmaceutical form: Powder;
Route of administration: Oral
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1.Male or Female patients between 18-70 years of age (Both Inclusive).
2. Patients and/or LAR must be able to understand the investigational nature of this study and to give written informed consent prior to the participation in the trial.
3. Patient with documented evidence of one of the following
a. Newly-diagnosed glioblastoma multiforme during monotherapy phase 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).
b. With malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma(anaplastic oligodendrogliomas and anaplastic oligoastrocytomas, and some less common tumours such as anaplastic ependymomas and anaplastic
gangliogliomas) showing recurrence or progression after standard therapy and
requiring above stated dosing.
4. Eastern Cooperative Oncology Group (ECOG) performance status.
5. Body mass index 18 to 30 kg/m2 (both inclusive) with minimum weight being 45 kg
6. Patients with adequate cardiac function defined as left ventricular ejection fraction
[LVEF] greater than equal to 50% and no other clinically significant findings on ECHO.
7. Patient should have recovered from any toxic effects of previous chemotherapy as judged
by the Investigator.
8. At least 4 weeks must have elapsed between the last day of radiotherapy and date of
randomization
9. Patients with life expectancy of at least 3 months.
10. Able to comply with study requirement in opinion of Investigator.
12. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time
of minor surgery; at least 4 weeks must have elapsed from the time of major surgery
13. Male patients must agree to use an effective contraceptive method throughout the study and for 6 month after last dose of Temozolomide.
14. Females of reproductive potential (which include girls who have entered puberty and all
women who have a uterus and ovaries and have not completed menopause), must use an
acceptable and effective method of avoiding pregnancy, starting from the first dose of
study drug until the end of study. Cessation of birth control after this point should be
discussed with a responsible physician. For this study, acceptable and effective methods
of contraception include-
-Tubal sterilization (tubal ligation performed more than one month before Study
Day 1; transcervical tubal occlusion procedure performed more than six months
before Study Day 1)
-Intrauterine Device (IUD)
-Progestin implant (i.e. Implanon or its equivalent)
-Progestin injection or progestin oral contraceptive pill plus one barrier method
(cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female
condom, or male condom)
-Two barrier methods used together (cervical cap, diaphragm, contraceptive
sponge, or vaginal spermicide plus a male or female condom)
-Absolute sexual abstinence (no sexual intercourse or genital contact with a male
partner).
In case of postmenopausal females (Menopause is the permanent end of menstruation and
fertility), menopause should be clinically confirmed by a patients healthcare provider.
Females who have 12 consecutive months of spontaneous amenorrhea (not amenorrhea
induced by a medical condition or medical therapy), need not use the contraceptive
measures specified above for females of reproductive potential.
The investigator should ensure that the patient is using an effective method of avoiding
pregnancy as per protocol.
ExclusionCriteria
Details
1. Pregnant or breast-feeding female.
2. Known hypersensitivity to Temozolomide, Dacarbazine or any other ingredients of the
formulation
3. Patient in need of receiving the study medication via nasogastric tube
4. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption
5. Active or history of opportunistic infection with mycobacteria, cytomegalovirus,
toxoplasma, P. carinii or other microorganism if under treatment with myelotoxic drugs.
6. Patients with severe hepatic impairment (Child pugh class C) or with renal impairment.
7. Use of any recreational drugs (cocaine, amphetamines, barbiturates, benzodiazepines,
cannabinoids and morphine) or history of drug or alcohol addiction
8. Pre-existing motor or sensory neurotoxicity of a severity greater than equal to grade 2 by NCI criteria.
9. Other serious illness or medical condition that would prohibit the understanding and
giving of informed consent.
10. A positive hepatitis screen including hepatitis B surface antigen or HCV antibodies.
11. Patients tested positive for HIV and/or syphilis.
12. The receipt of an investigational product, or participation in a drug research study within a period of 30 days prior to the first dose of investigational Product (Elimination half-life of the study drug should be taken into consideration for inclusion of the patient in the study).
13. Any other condition/Abnormal baseline that, in the investigator’s judgment, might
increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
14. Donation / loss of blood (without replenishment) (1 unit or 350 mL) within 90 days prior to receiving the first dose of study medicine.
15. Uncontrolled hypertension (systolic blood pressure [BP] greater than 140 or diastolic BP greater than 90mm Hg) or uncontrolled cardiac arrhythmias (Patients with hypertension controlled by antihypertensive therapies are eligible).
16. Patients who are smokers or tobacco users in any form.
17. Patients of reproductive potential unwilling to use acceptable contraception (as defined in the protocol inclusion criteria).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To characterize the pharmacokinetic profile and to compare bioavailability of test formulation with reference formulation.
pre-dose (0.0 hour) and at 0.083, 0.167, 0.333, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0 and 12.0 hours.
Secondary Outcome
Outcome
TimePoints
To evaluate taste/palatability of the sponsor’s test product.
Taste/flavour/mouth feel assessment will be done after 10 seconds
and 5 minutes of dosing for investigational medicinal product (test).
Target Sample Size
Total Sample Size="14" Sample Size from India="14" 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)
19/04/2021
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="7" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Not applicable
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This will be a multicentric, randomized, two-way, crossover study to evaluate comparative bioavailability of Temozolomide in patients of malignant gliomas under-going treatment.
The study will be conducted as a two-stage sequential design applying Potvin et al method C.