| CTRI Number |
CTRI/2010/091/000328 [Registered on: 31/12/2010] |
| Last Modified On: |
14/08/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
|
|
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
Bioequivalence Study of 6-Mercaptopurine in Adult patients with Acute Lymphoblastic Leukemia. |
Scientific Title of Study
Modification(s)
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An Open Label, Balanced, Randomized, Multicentre, Single-Dose, Three-Period, Two-Treatment, Three-Sequence, Crossover Comparative Bioequivalence Study of Two Formulations of 6-Mercaptopurine in Adult patients with Acute Lymphoblastic Leukemia (ALL) under fasting condition. |
| Trial Acronym |
Nill |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ARL/CT/09/003 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Agam Shah |
| Designation |
Lead Research Coordinator Clinical Trials |
| Affiliation |
NIL |
| Address |
Accutest Research Lab. Pvt. Ltd., Opp. The Grand Bhagawati Hotel,
S.G.Highway, Bodakdev,
Ahmadabad
GUJARAT
380059
India |
| Phone |
07940029312 |
| Fax |
07940029317 |
| Email |
agam.shah@accutestindia.com |
|
Details of Contact Person
Public Query
Modification(s)
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| Name |
Mr Prasann Bavania |
| Designation |
Sr. Research Associate |
| Affiliation |
|
| Address |
Accutest Research Lab. Pvt. Ltd., Opp. The Grand Bhagawati Hotel,
S.G.Highway, Bodakdev,
Ahmadabad
GUJARAT
380059
India |
| Phone |
07940029312 |
| Fax |
07940029317 |
| Email |
prasann.bavania@accutestindia.com |
|
Source of Monetary or Material Support
Modification(s)
|
| CRO: Accutest Research Laboratories (I) Pvt. Ltd., India |
| Sponsor: Orion Corporation, Finland |
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Primary Sponsor
Modification(s)
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| Name |
Orion Pharma |
| Address |
Orion Corporation,
Orion Pharma
P.O. Box 425
FI-20101 Turku, Finland |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Babita Hapani |
Ananya Oncology & Hematology Centre |
Ananya Oncology & Hematology Centre, 404/5, Hem Arcade,Opp. Swami Vivekanand Statue, Dr. Yagnik Road-360002
Rajkot
GUJARAT |
9825074345
babitahapani@hotmail.com |
| Dr Joseph Jebasingh |
Asirvatham Speciality Hospital |
22, Rajaji Street, Gandhi Nagar, Madurai - 625020
Madurai
TAMIL NADU |
09047031977
jjebasingh@gmail.com |
| Dr Seema Bhatwadekar |
Bhailal Amin General Hospital |
Department of Hematology, Bhailal Amin General Hospital, Gorwa Road,Subhanpura-390003
Vadodara
GUJARAT |
9374511709
ssbkar16@gmail.com |
| Dr Smita Uday Gupte |
Cancer Clinic |
Cancer Clinic,Block No -208, 2nd floor, Shrieewardhan complex,Ramdaspeth-440012
Nagpur
MAHARASHTRA |
9373107176
smita_gupte@rediffmail.com |
| Dr Avinash Pophali |
Central India Institute of Hematology & Oncology |
Central India Institute of Hematology & Oncology, 14/2, Park Corner, Balraj Marg,Near Lokmat Square, Dhantoli-440010
Nagpur
MAHARASHTRA |
982222576
ciihonagpur@gmail.com |
| Dr KK Mukherjee |
Chittaranjan National Cancer institute |
Department of Medical Oncology, Chittaranjan National Cancer institute, 37,S.P. Mukherjee Road-700026
Kolkata
WEST BENGAL |
9830115905
kkmukherjee4u@hotmail.com |
| Dr Sachin Hingmire |
Deenanath Mangeshkar Hospital and Research Centre |
Erandwane, Pune 411004.
Pune
MAHARASHTRA |
02040151000
sshingmire@yahoo.com |
| Dr Avtar Ganju |
Ganju Hematology Clinic & Hospital |
6th Floor, Midas Heights, Central Bazaar Road,
Ramdas Peth, Nagpur – 440012
Nagpur
MAHARASHTRA |
09422110765
avatarganju@yahoo.com |
| Dr Shriram Kane |
Hematology- Oncology Clinic |
Hematology- Oncology Clinic, Park Corner, Balraj Road - Abhyankar Road junction, Dhantoli, Nagpur – 440012
Nagpur
MAHARASHTRA |
07122433576
shriramkane@gmail.com |
| Dr Utpal Chaudhuri |
Institute of Hematology and Transfusion Medicine |
Institute of Hematology and Transfusion Medicine, 3rd floor, MCH Building,Medical College, 88 College Street-700073
Kolkata
WEST BENGAL |
9433018899
prantar@gmail.com |
| Dr Madatha Vijay Ramanan |
Jehangir Clinical Development Centre Pvt. Ltd. |
Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital, 32, Sasson Road, Near Pune Railway Station,Bund Garden road, Sangamvadi-411001
Pune
MAHARASHTRA |
9325315471
drvijayr@gmail.com |
| Dr Nirajkumar N Bhatt |
Kailash Cancer Hospital and Research Centre |
Medical Oncology, Kailash Cancer Hospital and Research Centre, Muni Seva Ashram,Waghodia-391760
Vadodara
GUJARAT |
9426568849
medonc12@gmail.com |
| Dr K C Lakshmaiah |
KIDWAI Memorial Institute of Oncology |
Department of Medical Oncology, KIDWAI Memorial Institute of Oncology, Dr. M. H. Marigodwa Road,Hosur Road-560029
Bangalore
KARNATAKA |
9448055949
kcluck@gmail.com |
| Dr Sharat Damodar |
Narayana Hrudalaya Hospitals |
Narayana Hrudalaya Hospitals, 258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore - 560099
Bangalore Rural
KARNATAKA |
08027835000
drsharat_damodar@yahoo.co.in |
| Dr Chinmay Kumar Basu |
Netaji Subhash Chandra Bose Cancer Research Institute |
Department of Oncology, Netaji Subhash Chandra Bose Cancer Research Institute, 16A ,Park Lane-700016
Kolkata
WEST BENGAL |
9830114880
ckbose@hotmail.com |
| Dr Alka Rani Khadwal |
Post Graduate Institute Medical Education & Research |
Department of Internal Medicine,
Post Graduate Institute Medical Education & Research, sector-12, Chandigarh – 160012.
Chandigarh
CHANDIGARH |
01722746018
alkakhadwal@hotmail.com |
| Dr Cecil Ross |
St. Johns Medical College and Hospital |
Department of Medicine, St. Johns Medical College and Hospital, Sarjapur Road, Sarjapur Road-560034
Bangalore
KARNATAKA |
9448493705
cecilross@bsnl.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Bhailal Amin Ethics Committee for Dr. Seema bhatwadekar |
Approved |
| Global Health Concern Ethics Committee, Nagpur for Dr. Avtar |
Approved |
| Institutional Ethical Review Board, St. Jhons Medical College & Hospital for Dr. Cecil Ross |
Approved |
| Institutional Ethics Committee for Dr. Chinmay Kumar Basu |
Approved |
| Institutional Ethics Committee for Dr. K.K. Mukherjee |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre, Pune |
Approved |
| Institutional Ethics Committee, Institute of hematology and transfusion medicine for Dr. Utpal Chaudhuri |
Approved |
| Institutional Ethics Committee, PGIMER, Chandigarh for Dr. Alka |
Submittted/Under Review |
| Institutional Review Board, Asirvatham Speciality Hospital for Dr. Joseph Jebasingh |
Approved |
| Jehangir Clinical Development Centre Institutional Review Board for Dr. Madatha Vijay Ramanan |
Approved |
| Medical Ethics Committee, KIDWAI memorial institute of oncology for Dr. K. C. Lakshmaiah |
Approved |
| Megpower Independent Ethics Committee for Dr. Avinash Pophali |
Approved |
| Megpower Independent Ethics Committee for Dr. Babita Hapani |
Approved |
| Megpower Independent Ethics Committee for Dr. Nirajkumar N. Bhatt |
Approved |
| Megpower Independent Ethics Committee for Dr. Shriram Kane |
Approved |
| Megpower Independent Ethics Committee for Dr. Smita Uday Gupte |
Approved |
| Narayana Hrudalaya Medical Ethics Committee for Dr. Sharat Damodar |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Lymphoblastic Leukemia (ALL), |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Mercaptopurine 50 mg tablet, Orion Pharma |
A single oral dose (multiples of 50 mg) will be administered as per randomization schedule in each period with approximately 240 mL of water at ambient temperature in sitting position. |
| Comparator Agent |
Mercaptopurine tablet USP 50 mg, TEVA Pharmaceuticals, USA |
A single oral dose (multiples of 50 mg) will be administered as per randomization schedule in each period with approximately 240 mL of water at ambient temperature in sitting position. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
The patients who qualify for the study should meet all of the following inclusion criteria.
1. Adult patients, either sex, aged between 18 ? 75 years (both inclusive).
2. Patients of acute lymphoblastic leukemia (ALL) on maintenance therapy with once daily oral 6-MP and once weekly methotrexate, and the additional drugs (for example Daunorubicin, Doxorubicin, L-asparaginase, Vincristine, Methotrexate and Steroids) as per institutional or hospital?s guidelines.
3. BMI between 18.5 kg/m2 ? 30 kg/ m2 both inclusive.
4. Patients Screening clinical laboratory results are within clinically acceptable range
5. Patients are willing and able to adhere to the study visit schedule and other protocol requirements as evidenced by signed written informed consent.
6. Women of child-bearing potential and all men must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm), intrauterine device (IUD), and abstinence (no sex). Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception while participating in the study;
7. Female patients of child-bearing potential must have a negative serum pregnancy test (beta-HCG) at screening and urine pregnancy test at the time of enrollment.
|
|
| ExclusionCriteria |
| Details |
The patients meeting with any of the following criteria should be excluded:
1. Adult patients with ALL on maintenance therapy with olsalazine, mesalazine, or sulphasalazine, warfarin, allopurinol, thioguanine, and drugs whose primary or secondary toxicity is myelosuppression (for example trimethoprim-sulfamethoxazole).
2. Patients with inherited deficiency of the TPMT enzyme.
3. Pregnancy, expected pregnancy or lactation within 6 months.
4. Patients who have a history of a known allergy/sensitivity to study drug or its excipients;
5. Patients who have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic(other than ALL), endocrine, pulmonary, cardiac, neurologic, or cerebral diseases;
6. Patients who have poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period;
7. Patients who have had a known substance abuse or dependency (drug or alcohol) within 3 years of screening;
8. Patients who are participating in any other clinical study or who have received treatment with any investigational drug or device within 1month prior screening;
Note: If the patient has participated in a study in which blood loss is more than 200 mL, patient can be dosed only after completion of 60 days from the previous study.
9. Patient who is part of the staff or a family member of the staff personnel directly involved with this study.
10. Any other condition that, in the investigator?s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory information needed to achieve the objectives of the study.
11. Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints.
12. Patients who have a known infection with human immunodeficiency virus (HIV) and/or hepatitis B or hepatitis C. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To characterize the pharmacokinetic profile of test formulation relative to that of the reference and to assess their bioequivalence. |
Multiple time points up to 8 hours in each period |
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Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
| To assess the safety and tolerability of the two formulations |
Through out the study period |
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Target Sample Size
Modification(s)
|
Total Sample Size="39"
Sample Size from India="39"
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
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
07/03/2011 |
| 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
Modification(s)
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is an Open Label, Balanced, Randomized, Multicentre, Single-Dose, Three-Period, Two-Treatment, Three-Sequence, Crossover bioequivalence study of two formulations of mercaptopurine in patients of acute lymphoblastic leukemia. It is expected that sponsor test formulation will show pharmacokinetics similar to that of the reference listed drug and will prove bioequivalent to the reference drug. The trial will be conducted in Indian patients only and within India only. The date for first patient screened for the study is March 07 2011. |