| CTRI Number |
CTRI/2011/11/002104 [Registered on: 04/11/2011] Trial Registered Prospectively |
| Last Modified On: |
29/08/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
This is a comperative study for the Etoposide 50 mg capsules manufactured with Etoposide 50 mg capsules of Mylan Inc. USA, in patients with small cell lung cancers under fasting condition. |
|
Scientific Title of Study
|
A randomized, multiple site, open label, two treatment, two period, two sequence, multiple-dose, crossover, bioequivalence study of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 10-VIN-195 Version:01 Dated:1-July-2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brijesh Wadekar |
| Designation |
Head Of Department |
| Affiliation |
Veeda Clinical Research Pvt. Ltd. |
| Address |
Veeda Clinical Research Pvt. Ltd., Insignia, Sindhu Bhavan Road, Bodakdev road, S. G. Highway, Ahmedabad
Veeda Clinical Research Pvt. Ltd., Insignia, Sindhu Bhavan Road, Bodakdev road, S. G. Highway, Ahmedabad
Ahmadabad
GUJARAT
380059
India |
| Phone |
079-30013000 |
| Fax |
079-30013010 |
| Email |
brijesh.wadekar@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brijesh Wadekar |
| Designation |
Head Of Department |
| Affiliation |
|
| Address |
Veeda Clinical Research Pvt. Ltd., Insignia, Sindhu Bhavan Road, Bodakdev road, S. G. Highway, Ahmedabad
GUJARAT
380059
India |
| Phone |
|
| Fax |
|
| Email |
brijesh.wadekar@veedacr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brijesh Wadekar |
| Designation |
Head Of Department |
| Affiliation |
|
| Address |
Veeda Clinical Research Pvt. Ltd., Insignia, Sindhu Bhavan Road, Bodakdev road, S. G. Highway, Ahmedabad
GUJARAT
380059
India |
| Phone |
|
| Fax |
|
| Email |
brijesh.wadekar@veedacr.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Banner Pharmacaps |
| Address |
Banner Pharmacaps
4125 Premier Dr,
High Point, NC 27265,
United states of America
Phone: 336-812-8700
Fax: 336-812-9091
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Mehta |
Central India Cancer Research Institute |
11, shankar Nagar, Nagpur 440010 Maharastra
Nagpur
MAHARASHTRA |
9823190192
ajayonco@hotmail.com |
| Dr G N Patel |
Jeevandeep Oncosurgical Hospital |
Jeevandeep Oncosurgical Hospital, 302, 3rd floor, Ayush building, Near Param Doctor House, Laldarwaja-Station Road, Surat.
Surat
GUJARAT |
9376913131
gnonco@gmail.com |
| Dr Niraj Bhatt |
Kailash Cancer Hospital and Research Centre |
Chemotherapy Day care Unit, ground floor, Muni Seva Ashram, Goraj, Dist: Vadodara 391760, Gujarat, India
Vadodara
GUJARAT |
9925581480
medonc12@gmail.com |
| Dr SPShrivastav |
Life Research Centre |
401, Param Doctor House,
Station Lal Darwaja Road,
Surat 395003
Ahmadabad
GUJARAT |
2612242862
crconcolrc@yahoo.com |
| Dr J K Singh |
Mahavir Cancer Sansthan |
Room no 222, 2nd floor,
Magadh Clinical Research, Phulwarisharif, Patna-801505, Bihar
Patna
BIHAR |
9431021001
drjksingh147@gmail.com |
| Dr Yathish kumar |
NRR Hospital |
NRR hospital OPD,
First Floor,
NRR Hospital, 3 & 3A, Hesaraghatta main road, Chikkasandra Near Chikkabanabara railawya station, Bangalore 560090
Bangalore
KARNATAKA |
9880462912
dryathish@hotmail.com |
| Dr Ramesh Arya |
Suyash Hospital |
AB road, Opposite MGM Medical College, Indore
Indore
MADHYA PRADESH |
73140456206
draryaramesh@gmail.com |
| Dr Shekhar Salkar |
Vintage Hospital and Research Centre |
Caculo Enclave, St. Inez,
Panaji, Goa 403001
North Goa
GOA |
8322363831
salkar.shekhar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Anveshhan Independent Ethics Committee (Ahmedabad)- Dr. Neeraj Bhatt |
Approved |
| Central India Cancer Research Institute (Nagpur)- Dr. Ajay Mehta |
Approved |
| Ethical Review Board, Mahavir Cancer Institute and Research Centre (Patna) - Dr. J. K. Singh |
Approved |
| Ethical Trial of Health In Community (ETHIC) Committee (Surat)- Dr. G. N. Patel |
Approved |
| Indore Independent Ethics Committee |
Approved |
| Institutional Ethics Committee, NRR Hospital (Banglore)- Dr. Yathish Kumar HM |
Approved |
| Research Independent Ethics Committee |
Approved |
| Vintage Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cancer Patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Etoposide 50 mg Capsule |
DOSE:50 mg/m2/day for 5 days
DURATION: 1 cycles
FREQUENCY: Every 21 Days
MODE OF ADMIN: Oral |
| Intervention |
Etoposide 50 mg capsules |
DOSE:50 mg/m2/day for 5 days
DURATION: 1 cycle
FREQUENCY: Every 21 Days
MODE OF ADMIN: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients aged 18years of age or older.
Patients already receiving etoposide and expected to receive at least two additional cycles at the same dose.
Eastern Cooperative Oncology Group (ECOG) performance status < 2.
Life expectancy > 3 months.
|
|
| ExclusionCriteria |
| Details |
The patients will be excluded from study, if they meet any of the following criteria:
Hypersensitivity to Etoposide or related class of drugs.
Extensive disease treatable with radiotherapy.
Past or current history of other malignant disease.
Concurrent severe medical problems other than small cell lung cancer.
Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.
Patient had a clinically significant history of cardiac disease;
Patient had pre-existing severe motor or sensory neuropathy higher than grade 1, according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (34); had active infections or other serious concomitant medical conditions that would impair the ability of a patient to receive the protocol treatment;
Patients with low serum albumin.
Patient had dementia.
Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study.
Women using a prohibited contraceptive method.
Women who are pregnant or breastfeeding.
Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above.
Known CYP450 strong inhibitors2 such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir or telithromycin and well known inducers2 such as rifampin, carbamazepine, rifabutin, rifapentin, dexamethasone, phenytoin, phenobarbital, and St. Johns wort within 1 month of the study starting.
History or presence of significant alcoholism or drug abuse in the past one year.
History or presence of significant smoking (more than 10 cigarettes or beedi’s/day).
History or presence of asthma, urticaria or other significant allergic reactions.
History or presence of significant gastric and/or duodenal ulceration.
History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
Difficulty with donating blood.
Difficulty in swallowing solids like tablets or capsules.
Patients with any other condition which in the Investigators opinion would not make the patient a good candidate for the clinical trial.
Severe medical problems other than the cancer that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
Participation in a drug research study within past 3 months.
Donation of blood in the past 3 months before screening.
Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
History or presence of significant easy bruising or bleeding.
History or presence of significant recent trauma.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the rate and extent of absorption of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions. |
The pre-dose blood sample of 3.5mL (0.00 hr) will be collected within 5 minutes prior to dosing time on Day 3, 4 and 5. On Day 5 the post-dose blood samples of 3.5mL each will be drawn at 15, 20, 30, 45 and 60 mins and then 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, and 48.00 hrs following drug administration in each period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To monitor the adverse events of Etoposide and to ensure the safety of patients. |
N/A |
|
|
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)
|
02/01/2012 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary Objective : To compare and evaluate the rate and extent of absorption of Etoposide 50mg Capsules of Banner Pharmacaps, USA compared with Etoposide 50mg Capsules of Mylan Inc., USA in adult patients with small cell lung cancer under fasting steady-state conditions. |