CTRI Trial Data
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PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 24 Sep 2021 03:06:33 GMT) 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 A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Study Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen® In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies. Secondary IDs if Any Secondary ID Identifier CRSC11002 Version 01 Date: 17/03/11 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr B S Chakraborty Trial Coordinator (multi-center study) Designation Sr. Vice President Affiliation CRO Cadila Pharmaceuticals Limited Address 1389 Trasad Road Dholka Ahmadabad GUJARAT 387810 India Phone 221481 Fax 220315 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ashish Akar Query) Designation Medical Monitor Affiliation CRO Cadila Pharmaceuticals Limited Address 1389 Trasad Road Dholka Ahmadabad GUJARAT 387810 India Phone 221481 Fax 220315 Email [email protected] Details Contact Details Contact Person (Public Query) 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 page 1 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Cadila Pharmacetutical Ltd 1389,Trasad road, dholka,ahmedabad-387810 > F.Hoffmann-La Roche Ltd,CH-4070, Basel, Switzerland Primary Sponsor Primary Sponsor Details Name Cadila Pharmaceuticals Ltd Address Corporate campus Sarkhej-Dholka Hihgway, Vill: Bhat, Ahmedabad - 382210 Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor CRO Cadila Pharmaceuticals Ltd 1389 Trasad Road Dholka Ahmedabad Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Meghraj Bardia Acharya tulsi regional S. P. Medical college & 09414451043 cancer treatment & a. G. Of hospitals, research centre Bikaner- 334 003 [email protected] Bikaner om RAJASTHAN Dr Tanveer Maksud Bharat Cancer Hospital Manavdaya Trust 2612641000 and Research Institute Complex, Surat-Bardoli 2612641004 Road, Saroli-395010 tanveermaksud@yahoo Surat .com GUJARAT DrDileep Shrinivasan Gurukrupa Hospital and 4/B, bhuyangdev cross 07927454181 Research Center road,bhuyangdev 07927499996 Society, Ghatlodia [email protected] Ahmadabad om GUJARAT DrAshish Kaushal HCG Medi-surge Mithakali cross Road, 9978297842 Hosptials pvt ltd Ellisbridge, 07926441401 Ahmedabad-380006 [email protected] Ahmadabad GUJARAT DrRajesh Makadia Mangalam Hospital 150 ring road, near kkv 9824255668 hall,rajkot Rajkot [email protected] GUJARAT Dr Ashish Netaji subhashchandra 16a park lane, West 9874210008 Mukhopadhyay bose cancer research bengal,Kolkata-700016. institute Kolkata heri.clinicaltrials@gmail WEST BENGAL .com Dr Siddhartha Basu Samaritan Nursing 10/4D Elgin Road, 98741166240 Home Kolakata-700020 Kolkata varghese2sanu@yahoo WEST BENGAL .co.in Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? “ETHIQUE” Approved 06/01/2012 Yes lndependent Ethics Committee page 2 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in “ETHIQUE” Approved 06/01/2012 Yes lndependent Ethics Committee “ETHIQUE” Approved 06/01/2012 Yes lndependent Ethics Committee Ethics Committee-NCRI Approved 14/02/2012 No Ethics Committee-S P Approved 09/02/2012 No Medical College, Bikaner ETHIQUE” Approved 06/01/2012 Yes lndependent Ethics Committee GCRI/GCS Ethics Approved 01/03/2012 No committee HCG Medi-Surge Ethics Approved 11/01/2012 No committee Regulatory Clearance Status Date Status from DCGI Approved/Obtained 02/06/2011 Health Condition / Health Type Condition Problems Studied Patients Patients on Myelosuppressive Therapy for Non Myeloid Malignancies Intervention / Type Name Details Comparator Agent 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 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 <br/> 2. Patients should have performance status of 0-2 ECOG (European Cooperative Oncology group (Appendix 3)<br/> 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. <br/> 4. Ability of patients to understand and the willingness to sign a written informed consent.<br/> Exclusion Criteria Exclusion Criteria Details 1. Subject with history or clinical evidence of serious benign medical illnesses including hepatic, renal, respiratory, cardiovascular, page 3 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in 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 Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Percentage of patients developing febrile 14 days 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. Secondary Outcome Outcome Timepoints Percentage of patients developing adverse 28 days 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 Target Sample Size Total Sample Size=150 Sample Size from India=150 page 4 / 5 PDF of Trial CTRI Website URL - http://ctri.nic.in Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 3 Date of First 11/01/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=4 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details 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. page 5 / 5 Powered by TCPDF (www.tcpdf.org).