| CTRI Number |
CTRI/2009/091/000694 [Registered on: 25/09/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs Peg G-CSF and Grafeel® in the prevention of reduction in neutrophil counts in cancer patients caused by drugs used to treat cancer. |
|
Scientific Title of Study
|
A randomized, multi-center, open label study to evaluate the efficacy and safety of Peg G-CSF as compared to Grafeel® in the prophylaxis of severe neutropenia in cancer patients receiving cytotoxic chemotherapy. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CDP/03/07 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Ramesh Nimmagadda |
| Designation |
|
| Affiliation |
|
| Address |
Director, Dept. of Medical Oncology, Apollo Specialty Hospital, No.320, Padma Complex, Mount Road
Teynampet
Chennai
TAMIL NADU
600035
India |
| Phone |
04424354956 |
| Fax |
04424362424 |
| Email |
ashaherf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rukmini Kethireddypally |
| Designation |
|
| Affiliation |
Dr. Reddy's Laboratories Ltd. |
| Address |
Director, Clinical Development Department, Biologics Development Center, Dr. Reddy's Laboratories Ltd.Survey No.47, Bachupalli,
Qutubullapur, R.R. District
Hyderabad
ANDHRA PRADESH
500090
India |
| Phone |
04044644340 |
| Fax |
04044644507 |
| Email |
rukminik@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Shivkumar Madki |
| Designation |
|
| Affiliation |
|
| Address |
Senior Manager, Clinical Development Department, Biologics Development Center, Dr. Reddy's Laboratories Ltd.Survey No.47, Bachupalli,
Qutubullapur, R.R. District
Hyderabad
ANDHRA PRADESH
500090
India |
| Phone |
04044644403 |
| Fax |
04044644507 |
| Email |
shivkumarm@drreddys.com |
|
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Source of Monetary or Material Support
|
| DR.REDDY'S LABORATORIES LTD, Hyderabad |
|
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Primary Sponsor
|
| Name |
DR.REDDY'S LABORATORIES LTD.Biologics Development Centre , Survey No.47, Bachupalli, Qutubullapur, Hyderabad-500090, A.P, India
Fax: +91-40-44644507, 91-40-23041418
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| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Pavithran |
Amrita institute of medical sciences |
AIMS Ponekkara P.O,-682041
|
04842802177
048402802177
pavithrank@aims.amrita.edu |
| Dr. Ramesh Nimmagadda |
Apollo Specialty Hospital |
No.320, Padma Complex, Mount Road,Teynampet-600035
Chennai
TAMIL NADU |
04424354956
04424362424
ashaherf@gmail.com |
| Dr. A. K. Vaid |
Artemis Medicare Services Pvt Ltd |
Sector-51,-122001
Gurgaon
HARYANA |
01246767997
ashok@artemishealthsciences.com |
| Dr. R. Gopal |
Asian Institute of Oncology, S.L. Raheja Hospital |
Raheja Hospital Marg,Mahim-400016
Mumbai
MAHARASHTRA |
02224449418
rgopal1@gmail.com |
| Dr. J S Sekhon |
Dayanand Medical College & Hospital |
Tagore Nagar,Civil Lines-141001
Ludhiana
PUNJAB |
01612304721
jagdevsekhon@hotmail.com |
| Dr. Chirag Desai |
Hemato-Oncology Clinic, Vedanta Institute of Medical Science |
Stadium Commerce College Road,Navarangpura-380009
Ahmadabad
GUJARAT |
07940042223
07940042225
chiragdesai.oncology@gmail.com |
| Dr. S.S. Nirni |
Indo American Cancer Institute and Research Centre |
Road No: 14, Banjara Hills,-500034
Hyderabad
ANDHRA PRADESH |
04023551235
04023542120
ssnirni@gmail.com |
| Dr. S H Advani |
Jaslok Hospital |
15, Dr. Deshmukh Marg,Pedder Road-400026
Mumbai
MAHARASHTRA |
02266573254
02223526833
shadvani2000@yahoo.com |
| Dr. Tarini Prasad Sahoo |
Jawaharlal Nehru Cancer Hospital & Research Centre |
Idgah Hills,-462001
Bhopal
MADHYA PRADESH |
07554255680
07552666094
tarini73@rediffmail.com |
| Dr. A. A. Ranade |
Joshi Hospital |
778, Shivajinagar, Opp Kamala,Nehrupark-411004
Pune
MAHARASHTRA |
02066023071
draaranade@yahoo.com |
| Dr. V. P. Gangadharan |
Lakeshore Hospital & Research Centre Ltd |
Department of Medical Oncology, Room No. 324,NH - 47 Bypass, Maradu, Nettoor -682040
|
04842701032
04842703573
gangavp1@gmail.com |
| Dr. Senthil Rajappa |
Nizam's Institute of Medical Sciences |
Punjagutta,-500082
Hyderabad
ANDHRA PRADESH |
04023327874
04066669049
siddharth142@sify.com |
| Dr. G S Bhattacharyya |
Orchid Nursing Home |
P-14, C-17 Road,Phoolbagan-700054
Kolkata
WEST BENGAL |
03323202729
03323202730
docgsbhattacharyya@gmail.com |
| Dr. Subramanian. S |
V.S. Hospitals Pvt. Ltd. |
13, East Spurtank Road,Chetpet-600031
Chennai
TAMIL NADU |
04442001000
04428191021
vshospitals@gmail.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| Artemis Heath Sciences Ethics Committee |
Submittted/Under Review |
| Ethics Committee of The Heart Care Clinic |
Approved |
| Ethics Committee, Apollo Hospitals Enterprise Limited |
Approved |
| Ethics Committee, Jaslok Hospital & Research Centre |
Approved |
| Ethics Committee, Madras Clinical Research Centre |
Approved |
| Ethics committee, Nizam's Institute of Medical Sciences |
Approved |
| Institutional Drug Trial Ethics Committee, Dayanand Medical College & Hospital |
Approved |
| Institutional Ethical Committee, Jawaharlal Nehru Cancer Hospital & Research Centre |
Approved |
| Institutional Ethical Review Board, Orchid Nursing Home |
Approved |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Indo-American Cancer Institute and Research Centre |
Approved |
| Institutional Ethics Committee, Joshi Hospital |
Approved |
| IRB, S.L. Raheja Hospital |
Approved |
| Lakeshore Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Adult patients with advanced NSCLC or metastatic breast cancer receiving cytotoxic chemotherapy (as per inclusion criteria) will be enrolled in the study., |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Grafeel® |
5µg/kg/day administered via SC route. |
| Intervention |
PEG-GCSF |
6 mg single dose administered via SC route |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1)Signed and dated written informed consent
2)Patients aged 18 to 70 years
3)Chemo naive patients
4)Patients diagnosed with unresectable stage IIIB or IV NSCLC or metastatic breast cancer requiring first line cytotoxic chemotherapy regimen associated with intermediate risk of febrile neutropenia and significant risk of severe neutropenia
5)Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
6)Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^9/L and Platelets greater than or equal to 100 x 10^9/L
7)Adequate liver function: bilirubin less than or equal to 1.5mg/dL, ALT/AST/ alkaline phosphatase less than 2 times the upper normal value (unless due to liver involvement in which case ALT/AST less than 4 times the upper normal value, and alkaline phosphatase without limit)
8)Adequate renal function: serum creatinine less than or equal to 1.5 mg/dL and GFR greater than or equal to 50 ml/min
9)If female:
Women without childbearing potential (eg. Post menopausal, surgery/ radiation therapy terminating reproductive potential etc)
OR
Women with childbearing potential using an approved contraceptive method (intrauterine device, birth control pills, or barrier device) during and for 3 months after completion of study, and having negative urine Beta-HCG test prior to study enrolment
|
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| ExclusionCriteria |
| Details |
1)Any clinically significant findings on history or examination that, in the opinion of the investigator, would preclude administration of chemotherapy and Grafeel®/ Peg G-CSF therapy in the full doses and clinically significant cardiac disease, neuropathy or other disease
2)Any active cancer or history of prior malignancy except carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or any surgically cured malignancies diagnosed 5 years or more before screening
3)Patients with Congestive Heart Failure class III/IV as per New York Heart Association classification
4)LVEF <50%, except patients receiving doxorubicin containing chemotherapy, wherein LVEF <55%
5)Clinically symptomatic brain metastases
6)A positive serologic test for the Human Immunodeficiency Virus (HIV) or unresolved Hepatitis B or C virus infection
7)Pregnant or breast-feeding women
8)Patients who have received any other investigative drugs within 30 days before randomization
9)History of allergic reactions to the study drug or its constituents
10)Previous exposure to any colony stimulating factor
11)Patients previously diagnosed with sickle cell disorder
12)Chronic use of oral corticosteroids (except low dose with no more than 20 mg/d prednisolone or equivalent for COPD)
13)Any illness or condition that in the opinion of the investigator could affect the safety of the patient
14)Radiation therapy within 4 weeks of randomization into this study
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Duration of severe (grade 4) neutropenia in cycle 1. |
3 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of severe neutropenia by cycle and across all cycles. |
18 weeks |
| Incidence of febrile neutropenia (FN) by cycle and across all cycles. |
18 weeks |
| ANC nadir, defined as patients lowest ANC for cycle 1. |
3 weeks |
| Time to ANC recovery, defined as the time in days from chemotherapy administration until patients ANC increased to ≥ 2.0 X 109/l after the expected nadir for cycle 1. |
3 weeks |
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Target Sample Size
|
Total Sample Size="150"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="9"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This study is a randomized, multi-center, open label study to evaluate the efficacy and safety of Peg G-CSF as compared to Grafeel® in the prophylaxis of severe neutropenia in 150 cancer patients receiving cytotoxic chemotherapy. Study duration includes 2 weeks of screening, 18 weeks of treatment with a follow-up period of 6 months and study will be conducted in 14 centers in India. Primary Objective is to establish non-inferiority of Peg G-CSF with Grafeel® for duration of severe (grade 4) neutropenia in cycle 1 of chemotherapy. |