| CTRI Number |
CTRI/2013/12/004205 [Registered on: 11/12/2013] Trial Registered Prospectively |
| Last Modified On: |
11/06/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A bio-equivalence study to characterize the rate and extent of absorption of Melphalan after oral
administration and to assess the bioequivalence of the sponsor’s test product
Melphalan Tablets 2 mg relative to that of the reference product ALKERAN®
(melphalan) Tablets 2 mg in adult patients |
|
Scientific Title of Study
|
An open label, multicentre, randomized, balanced, two-treatment, two-period,
two-sequence, single dose, crossover, oral bioequivalence study of Melphalan Tablets 2 mg sponsor company compared with that of ALKERAN® (melphalan) Tablets 2 mg of GlaxoSmithKline, USA in adult
patients under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCS-124-12-CS Version 3.0 dated 02 JUL 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeev Siddaraj |
| Designation |
Head - Clinical Trials |
| Affiliation |
Norwich Clinical Services Pvt. Ltd. |
| Address |
Norwich Clinical Services Pvt. Ltd.
147/F, 3rd Block, 8th Main, Koramangala, Bangalore
Bangalore
KARNATAKA
560 034
India |
| Phone |
09448088817 |
| Fax |
|
| Email |
rajeev.siddaraj@norwichclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Siddaraj |
| Designation |
Head - Clinical Trials |
| Affiliation |
Norwich Clinical Services Pvt. Ltd. |
| Address |
Norwich Clinical Services Pvt. Ltd.
147/F, 3rd Block, 8th Main, Koramangala, Bangalore
Bangalore
KARNATAKA
560 034
India |
| Phone |
09448088817 |
| Fax |
|
| Email |
rajeev.siddaraj@norwichclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Siddaraj |
| Designation |
Head - Clinical Trials |
| Affiliation |
Norwich Clinical Services Pvt. Ltd. |
| Address |
Norwich Clinical Services Pvt. Ltd.
147/F, 3rd Block, 8th Main, Koramangala, Bangalore
Bangalore
KARNATAKA
560 034
India |
| Phone |
09448088817 |
| Fax |
|
| Email |
rajeev.siddaraj@norwichclinical.com |
|
|
Source of Monetary or Material Support
|
| Norwich Clinical Services Pvt Ltd. |
|
|
Primary Sponsor
|
| Name |
Alvogen Pine Brook Inc |
| Address |
Alvogen Pine Brook Inc.
10 Bloomfield Avenue, Building B, Pine Brook, NJ 07058 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeba singh |
Asirvatham Speciality Hospital |
Department of Oncology
22, Rajaji Street, Gandhi Nagar,
Madurai - 625020
Madurai
TAMIL NADU |
09442619775
asirvathamcrc@gmail.com |
| Dr V Satya Suresh Attili |
Bibi General Hospital and Cancer centre |
16-3-991/1/c, Govt Printing Press Road, Malakpet, Hyderabad 500024
Hyderabad
ANDHRA PRADESH |
09246243034
sureshattili@yahoo.com |
| Dr Swathi |
M.S. Ramaiah Medical College and Teaching Hospital |
1st Floor, M.S.Ramaiah Advanced Learning Centre,Gnanagangothri Campus, Gate-4
Bangalore
KARNATAKA |
09538969888
swathi@msrcrc.com |
| Dr Krishna Kumar Rathnam |
Meenakshi Mission Hospital and Research Centre |
Department of Oncology,
Lake Area, Melur Road & Madurai, 625 107.
Tamil Nadu,India.
Madurai
TAMIL NADU |
04522588741
kkrathnam@gmail.com |
| Dr Satheesh C T |
Sree Venkateshwara Hospital |
No.46, Madiwala, Hosur Main Road, Bangalore -560068
Bangalore
KARNATAKA |
09242698750
svhospitalresearch@gmail.com |
| DrCecil Ross |
St. Johns Medical College Hospital |
Sarjapur Road, Bangalore-560034
Bangalore
KARNATAKA |
08022065229
cecilross@sify.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Asirvatham Speciality Hospital |
Approved |
| BIBI Institutional Ethics Committee |
Approved |
| M S Ramaiah |
Approved |
| Meenakshi Mission Hospital and Research Center |
Approved |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
| ST Johns Medical College and Hospital IRB |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with confirmed diagnosis of multiple myeloma or ovarian cancer for whom oral Melphalan is indicated., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ALKERAN® (melphalan) Tablets 2 mg |
After a supervised overnight fast, patients will receive a single oral dose of the assigned reference product ALKERAN® (Melphalan Tablets 2 mg) with about 240 mL of ambient water. |
| Comparator Agent |
Melphalan 2mg Tablets |
After a supervised overnight fast, patients will receive a single oral dose of the
assigned test Melphalan Tablets 2 mg with about 240 mL of ambient water. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with confirmed diagnosis of multiple myeloma or ovarian cancer for whom oral Melphalan is indicated.
2. Patients aged 18 years or above.
3. Patients who did not receive the last dose of melphalan or nonmelphalan chemotherapy in the last 4 weeks prior to the first dose of the study medication.
4. Patients agree to participate in the study and give their written informed consent.
5. Patients who agree to comply with study procedures and the schedule of clinical and follow-up visit.
6. Patients with ECOG (Eastern Cooperative Oncology Group)performance status score of 0-2. |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
2. Patients who received mitomycin C within 8 weeks prior to the first dose of the study.
3. Patients who had a significant surgery within 2 weeks prior to enrolling in study and as per the investigator, their inclusion may affect the
objective of the study.
4. Patients having metastatic disease involving the central nervous system.
5. Patients who are scheduled to receive radiotherapy during the study period.
6. Patients with leukocyte count below 3,000 cells/mcL or the platelet count below 100,000 cells/mcL.
7. Previous enrollment in this study or participating in any other study in the past 30 days.
8. Any uncontrolled medical problem, e.g. heart, lung disease or clinically significant abnormal laboratory values that in the opinion of the investigator and/or sponsor would preclude safe administration of the study drug.
9. Patients with history or presence of renal insufficiency and and azotemia.
10. History or presence gastrointestinal ulceration, bleeding and/or perforation.
11. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and alcohol breath analysis
12. Difficulty in swallowing tablets.
13. Positive urine drug screening, alcohol breath analysis, HIV, VDRL/RPR, Hepatitis B & C tests.
14. Female patients demonstrating a positive pregnancy screen or currently breast-feeding.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To characterize the rate and extent of absorption of Melphalan after oral
administration and to assess the bioequivalence |
The pre-dose (0.00 hour) blood sample (each 4 mL) will be collected within 1 hour prior to dosing. The post-dose blood samples (each 4 mL) will be collected at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 5.00, 6.00 and 8.00 hours after dosing. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To investigate the safety and tolerability of both the formulations. |
basis of clinical and laboratory examination, documentation of the Adverse Events |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
Modification(s)
|
26/12/2013 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
No data available yet for publication on this study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is An open label, multi-centre, randomized, balanced, two treatment, two period, two sequence, single dose, crossover, oral bio-equivalence study in adult patients under fasting conditions. Patients diagnosed with multiple myeloma or ovarian cancer requiring oral melphalan will be included in this study.
Study Objective:
To characterize the rate and extent of absorption of Melphalan after oral administration and to assess the bioequivalence of the sponsor’s test product
Melphalan Tablets 2 mg relative to that of the reference product ALKERAN® (melphalan) Tablets 2 mg in adult patients of either sex under fasting conditions.
and To investigate the safety and tolerability of both the formulations on the basis of clinical and laboratory examination, documentation of the Adverse Events.
|