| CTRI Number |
CTRI/2012/02/002397 [Registered on: 02/02/2012] Trial Registered Retrospectively |
| Last Modified On: |
18/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of GCSF in Patients on Myelosuppresive Therapy for Non-Myeloid Malignancies. |
|
Scientific Title of Study
|
A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen® In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRSC11002 Version 01 Date: 17/03/11 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B S Chakraborty |
| Designation |
Sr. Vice President |
| Affiliation |
CRO Cadila Pharmaceuticals Limited |
| Address |
1389 Trasad Road Dholka
Ahmadabad
GUJARAT
387810
India |
| Phone |
221481 |
| Fax |
220315 |
| Email |
drb.chakraborty@cadilapharma.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Akar |
| Designation |
Medical Monitor |
| Affiliation |
CRO Cadila Pharmaceuticals Limited |
| Address |
1389 Trasad Road Dholka
Ahmadabad
GUJARAT
387810
India |
| Phone |
221481 |
| Fax |
220315 |
| Email |
ashish.akar@cadilapharma.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhaumik Mody |
| Designation |
Project Manager |
| Affiliation |
CRO Cadila Pharmaceuticals Limited |
| Address |
1389 Trasad Road Dholka
Ahmadabad
GUJARAT
387810
India |
| Phone |
|
| Fax |
|
| Email |
bhaumik.mody@cadilapharma.co.in |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmacetutical Ltd
1389,Trasad road, dholka,ahmedabad-387810 |
| F.Hoffmann-La Roche Ltd,CH-4070, Basel, Switzerland |
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceuticals Ltd |
| Address |
Corporate campus Sarkhej-Dholka Hihgway,
Vill: Bhat, Ahmedabad - 382210
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CRO Cadila Pharmaceuticals Ltd |
1389 Trasad Road Dholka Ahmedabad |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meghraj Bardia |
Acharya tulsi regional cancer treatment & research centre |
S. P. Medical college & a. G. Of hospitals,
Bikaner- 334 003
Bikaner
RAJASTHAN |
09414451043
directorrccbkn@gmail.com |
| Dr Tanveer Maksud |
Bharat Cancer Hospital and Research Institute |
Manavdaya Trust Complex,
Surat-Bardoli Road,
Saroli-395010
Surat
GUJARAT |
2612641000
2612641004
tanveermaksud@yahoo.com |
| DrDileep Shrinivasan |
Gurukrupa Hospital and Research Center |
4/B, bhuyangdev cross road,bhuyangdev Society, Ghatlodia
Ahmadabad
GUJARAT |
07927454181
07927499996
iroclincaltrials@gmail.com |
| DrAshish Kaushal |
HCG Medi-surge Hosptials pvt ltd |
Mithakali cross Road,
Ellisbridge,
Ahmedabad-380006
Ahmadabad
GUJARAT |
9978297842
07926441401
drashish4@yahoo.co.in |
| DrRajesh Makadia |
Mangalam Hospital |
150 ring road, near kkv hall,rajkot
Rajkot
GUJARAT |
9824255668
drrajesh.cr@gmail.com |
| Dr Ashish Mukhopadhyay |
Netaji subhashchandra bose cancer research institute |
16a park lane,
West bengal,Kolkata-700016.
Kolkata
WEST BENGAL |
9874210008
heri.clinicaltrials@gmail.com |
| Dr Siddhartha Basu |
Samaritan Nursing Home |
10/4D Elgin Road,
Kolakata-700020
Kolkata
WEST BENGAL |
98741166240
varghese2sanu@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| “ETHIQUE†lndependent Ethics Committee |
Approved |
| “ETHIQUE†lndependent Ethics Committee |
Approved |
| “ETHIQUE†lndependent Ethics Committee |
Approved |
| Ethics Committee-NCRI |
Approved |
| Ethics Committee-S P Medical College, Bikaner |
Approved |
| ETHIQUE†lndependent Ethics Committee |
Approved |
| GCRI/GCS Ethics committee |
Approved |
| HCG Medi-Surge Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients on Myelosuppressive Therapy for Non Myeloid Malignancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cadila G-CSF |
Cadila rh G-CSF in the dose of 300 micro gram once/ day for a maximum of 14 days (or till post nadir absolute neutrophil count reaches to ≥10000/cubic mm) by sub cutaneus route. |
| Comparator Agent |
Neupogen |
Neupogen in the dose of 300 micro gram once/ day for a maximum of 14 days (or till post nadir absolute neutrophil count reaches to ≥10000/cubic mm) by sub cutaneus route. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subject of either sex aged 18 years or more having any Histologically confirmed malignancy (except myeloid malignancies and myelodysplastic syndromes) undergoing a variety of myelosuppressive chemotherapy regimens
2. Patients should have performance status of 0-2 ECOG (European Cooperative Oncology group (Appendix 3)
3. Subjects with ≥ 20% risk of developing chemotherapy induced febrile neutropenia. Subjects receiving chemotherapy regimens with (Appendix 6), National Comprehensive Cancer Network (NCCN) guideline for myeloid growth factor v.1.2008) intermediate to high risk for febrile neutropenia are eligible.
4. Ability of patients to understand and the willingness to sign a written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Subject with history or clinical evidence of serious benign medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the Investigator with or without specific investigations.
2. Patient has any condition which is considered as a contraindication for the use of GCSF or which, in the opinion of the Investigator may put the patient increased risk versus any supposed benefit of treatment with GCSF.
3. Subject with body weight 45 kg
4. Patients have any prior history of bone marrow / stem cell transplantation or may require in near future in the Investigator’s opinion
5. Patients having active infection
6. Patients who have clinically significant uncontrolled medical illness except malignancy
7. Patients having renal impairment (serum creatinine ≥ 1.5 times the upper normal limit) and abnormal liver function total bilirubin ≥ 2 times the upper limit of normal, SGOT & SGPT ≥ 5 times the upper limit of normal)
8. Patients who have involvement of bone marrow
9. Patients receiving simultaneous radiotherapy
10. Current therapy with other investigational drugs or lithium.
11. History or clinical evidence of congestive heart failure (NYHA class III-IV). (Appendix 4)
12. Prior treatment with antibiotics, interferons, interleukins, or, colony stimulating factors (including G-CSF, GM- CSF, M-CSF and erythropoietin) within last 10 days of enrolment.
13. Pregnant women, nursing women and women not practicing effective contraception.
14. Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication.
15. Patients with clinical symptoms of acute Hepatitis B or C infection.
16. Patients unwilling to give informed consent or unable to follow study procedures
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of 38°C twice in a 12-hour period and absolute neutrophil count 0.5 x 10e9/L on the same day of the fever or the day after. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients developing adverse events and/ or changes in laboratory values.
Incidence of neutropenia defined as absolute neutrophil count 0.5 x 10e9/L not associated with fever
• Incidence of need for IV anti-infectives and days of admission, as a result of neutropenia
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen® In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies. Patients who meet the eligibility criteria at screening visit will be enrolled into the study.
Safety assessments will include physical examinations, vital signs, clinical laboratory evaluations (blood chemistry, urinalysis, and hematology), and adverse event and serious adverse event monitoring. |