| CTRI Number |
CTRI/2010/091/000109 [Registered on: 03/08/2010] |
| Last Modified On: |
07/04/2011 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
A post marketing surveillance trial to study the safety and efficacy of two drugs, Neupeg and Neulastim in female patients with advanced breast cancer |
|
Scientific Title of Study
|
"A Prospective, Comparative, Randomized, Multicenteric, Open label Post Marketing Surveillance study to compare the Safety and efficacy of once-per-cycle Peg Filgrastim (6 mg/0.6 ml) of Intas Biopharmaceuticals Ltd. to NEULASTIM of ROCHE in support of AT chemotherapy in females patients with Advanced (Stage III and IV) breast cancer" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IBPL_PF_01 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vimal Sanghavi |
| Designation |
|
| Affiliation |
|
| Address |
Oncology Services India Ltd
S G Highway
Ahmadabad
GUJARAT
380015
India |
| Phone |
07966074100 |
| Fax |
07966074101 |
| Email |
communication@os-india.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimal Sanghavi |
| Designation |
|
| Affiliation |
|
| Address |
Oncology Services India Ltd
S G Highway
Ahmadabad
GUJARAT
380015
India |
| Phone |
07966074100 |
| Fax |
07966074101 |
| Email |
communication@os-india.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimal Sanghavi |
| Designation |
|
| Affiliation |
|
| Address |
Oncology Services India Ltd
S G Highway
Ahmadabad
GUJARAT
380015
India |
| Phone |
07966074100 |
| Fax |
07966074101 |
| Email |
communication@os-india.com |
|
|
Source of Monetary or Material Support
|
| Intas Biopharmaceuticals Limited |
|
|
Primary Sponsor
|
| Name |
Intas Biopharmaceuticals Limited
|
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Tanveer M Maksud |
Bharat Cancer Hospital & Research Institute |
Surat-bardoli Road,Saroli-394 211
Surat
GUJARAT |
+91 261 2641000
+91 261 2641005
tanveermaksud@yahoo.com |
| Dr. Smita Gupte |
Cancer Clinic |
208,Shreevardhan Complex,,Ramdaspeth,Wardha Road,-440012
Nagpur
MAHARASHTRA |
+91 712 2444729
smita_gupte@rediffmail.com |
| Dr. Ajay Mehta |
Central India Cancer Research Institute |
11,Shankar Nagar,,West High Court Road,-440 010
Nagpur
MAHARASHTRA |
+91 712 2520956
+91 712 2523404
ajayonco@hotmail.com |
| Dr. C. Haritha |
M.S.Patel Cancer Centre |
Shree Krishna Hospital,Gokalnagar-388325
|
+91 2692 222130
+91 2692 223466
chiramanah@charutarhealth.org |
| Dr. Rajesh Makadia |
Mangalam Hospital |
Opp. Prasang Hall, ,Near KKV Hall, 150 ft ring road-360005
Rajkot
GUJARAT |
+91-9824255668
makadiamonali@yahoo.co.in |
| Dr. Ashish Kaushal |
Medisurge Hospital |
Mithakhali Six Roads,,Ellis Bridge-380 006
Ahmadabad
GUJARAT |
91 79 4001 0101
+91 79 4001 0103
drashish4@yahoo.co.in |
| Dr. Babita Hapani |
Private Clinic |
4th 404,405, Hem Arcade, Vivekanand chawk, , Dr. Yagnik Road, Opp. Swami Vivekanand Statue-360002
|
+91-9825074345
babitahapani@hotmail.com |
| Dr.Preety Jain |
Private Clinic |
16/2,K.E.H. Compound,,Opp. Agrawal Dharmshala,M.Y.H.Road,-
Indore
MADHYA PRADESH |
jainpreety2005@yahoo.com |
| Dr. Pradeep Shah |
Shreyas Medical Clinic |
2,Premal Appartment,Nr.GPO,Raopura,-390 001
Vadodara
GUJARAT |
+91 265 2425083
pradeeprshah@msn.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| HCG Medisurge Ethics Committee |
Approved |
| Human Research Ethics Committee-Dr. C Haritha |
Approved |
| Independent Ethics Committee-ADITYA For Dr. Ajay Mehta |
Approved |
| Independent Ethics Committee-ADITYA For Dr. Babita Hapani |
Approved |
| Independent Ethics Committee-ADITYA For Dr. Pradeep Shah |
Approved |
| Independent Ethics Committee-ADITYA For Dr. Preety Jain |
Approved |
| Independent Ethics Committee-ADITYA For Dr. Rajesh Makadia |
Approved |
| Independent Ethics Committee-ADITYA For Dr. Smita Gupte |
Approved |
| Independent Ethics Committee-ADITYA for Dr. Tanveer Maksud |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Advanced(Stage III & IV) Breast Cancer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neulastim |
6mg/0.6ml |
| Intervention |
Peg Filgrastim |
6mg/0.6ml |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1.Female Patients aged 18 years and above suffering from advanced (Stage III and IV) Breast Cancer eligible for receiving AT (Docetaxel- 75 mg/m2, Doxorubicin- 50 mg/m2) chemotherapy.
2.GCSF and Peg- GCSF naive patients
3.ANC > 1,500/uL
4.Hemoglobin > 9 g/dL
5.Platelets > 100,000/ul
6.Patients with serum creatinine ≤ 1.5 mg/dL
7.AST/ALT < 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Bilirubin ≤ 2 x ULN
8.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study
9.Patients able to adhere to the study visit schedule and other protocol requirements
10.Completion of previous chemotherapy more than 4 weeks before randomization
|
|
| ExclusionCriteria |
| Details |
1.History of prior malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukemia?s) or Any premalignant myeloid condition other than breast cancer with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy ?
2.Documented active infection at the time of enrolment requiring use of systemic anti- infective or use of any anti infective ≤ 72 hours before the study drug administration.
3.Documented positive test for human immunodeficiency virus (HIV) infection ? known hypersensitivity to E coli derived products [e.g., Filgrastim pegfilgrastim HUMULIN® Insulin, L-1Asparaginase, HUMATROPE® Growth Hormone, INTRON A®]
4.Subject is currently enrolled in or 4 weeks have not passed since completing other device or drug trial(s) or is receiving other investigational agent(s) other than placebo (confirmation of prior treatment must be documented)
5.Pregnant or breast-feeding (for subjects of child bearing potential) patients or patients not using adequate contraception (for subjects of child bearing potential)
6.Previous participation in this study - Inability or unwillingness to comply with the protocol procedures
7.Had undergone prior radiation therapy within 4 weeks of randomization into this study (with the exception of spot radiation for bone metastases),
8.Prior bone marrow or stem-cell transplantation, or Prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m2 or epirubicin more than 600 mg/m2.
9.Clinically symptomatic brain metastasis
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy endpoint will be |
Duration of severe Neutropenia (defined as ANC < 0.5 × 109/L) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary efficacy endpoints |
?Depth of ANC count(nadir) in each cycles as compared to baseline
?Incidence of Febrile Neutropenia ? (Defined as a rise in axillary temperature to >38.5 °C for a duration of more than 1 hour while having an absolute neutrophil count < 0.5 × 109 /l)
?Incidence of severe Neutropenia(defined as ANC < 0.5 × 109/L)
?Time to ANC recovery
?Use of Antibiotics for the treatment of Febrile Neutropenia
|
|
|
Target Sample Size
|
Total Sample Size="100"
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" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/07/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
?A Prospective, Comparative, Randomized, Multicenteric, Open label Post Marketing Surveillance study to compare the Safety and efficacy of once-per-cycle Peg Filgrastim (6 mg/0.6 ml) of Intas Biopharmaceuticals Ltd. to NEULASTIM of ROCHE in support of AT chemotherapy in females patients with Advanced (Stage III and IV) breast cancer? |