| CTRI Number |
CTRI/2009/091/001016 [Registered on: 13/01/2010] |
| Last Modified On: |
23/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Phase III clinical trial to compare the efficacy and safety of pegylated granulocyte colony stimulating factor(Peg G-CSF) versus granulocyte colony stimulating factor (G-CSF) in nonmyeloid malignancies subjects. |
Scientific Title of Study
Modification(s)
|
Randomized, comparative, Phase III clinical trial to compare the efficacy and safety of recombinant human pegylated granulocyte colony stimulating factor(Peg G-CSF) versus granulocyte colony stimulating factor (G-CSF) in subjects with nonmyeloid malignancies receiving myelosuppressive chemotherapy. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| P3-Peg G-CSF-02 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rakesh Chugh |
| Designation |
DGM |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Bandra, Mumbai, India
Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Bandra
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596203 |
| Fax |
02226523885 |
| Email |
rchugh@wockhardt.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Rakesh Chugh |
| Designation |
DGM |
| Affiliation |
NA |
| Address |
Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Bandra, Mumbai
Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Bandra
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596203 |
| Fax |
02226523885 |
| Email |
rchugh@wockhardt.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ashima Bhatia |
| Designation |
Sr. VP |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Bandra, Mumbai, India
Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Bandra, Mumbai, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
09871790639 |
| Fax |
02226523885 |
| Email |
abhatia@wockhardt.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Wockhardt Limited, Wockhardt Towers, Bandra-Kurla Complex,
Bandra (E), Mumbai 400051, India
Tel: 022- 2659 6402 (O) Fax: 022- 26523885 |
|
Primary Sponsor
Modification(s)
|
| Name |
Wockhardt Limited |
| Address |
Wockhardt Limited, Wockhardt Towers, Bandra-Kurla Complex, Bandra (E), Mumbai 400051, India Tel: +912226596402(O) Fax: +912226523885 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. P.P. Bapsy |
Apollo Hospitals |
No 154/11, Opp IIMB , ,Bannerghatta Road,-560 076
Bangalore
KARNATAKA |
09845624793
ppbapsy@yahoo.com |
| Dr Radheshyam Naik |
Bangalore Institute of Oncology |
Triesta Sciences - A Division of Healthcare Global Enterprises Limited,HCG Towers, No.8, P. Kalinga Rao Road, Sampangi Rama Nagar -560027
Bangalore
KARNATAKA |
91-9731310682
radheshyam_n@yahoo.com |
| Dr Shriram B Kane |
Clinical Hematologist & Oncophysician |
Swapnil Apartments,Abhyankar Road, Dhantoli-440012
Nagpur
MAHARASHTRA |
09823012851
NIL
shriramkane@gmail.com |
| Dr Shona Nag |
Jehangir Hospital,Department of Oncology, |
Sassoon Road,-411001
Pune
MAHARASHTRA |
093710 72441
NIL
shona_nag@hotmail.com |
| Dr Poonam Patil |
Manipal Hospital |
Airport Road,-560017
Bangalore
KARNATAKA |
09945687185
NIL
poonampatil@yahoo.com |
| Dr Suresh Sanchetee |
Sanchetee Hospital and Cancer Institute |
429,Pal Link road,-342008
Jodhpur
RAJASTHAN |
91-291-2752666
rccure@gmail.com |
| Dr Minish Jain |
Sanchetee Hospital and Cancer Institute, |
3rd floor, 40 Sassoon road,,-411001
Pune
MAHARASHTRA |
09823133390
minishjain009@gmail.com |
| Dr Naresh Somani |
Somani Hospital and Research Center |
277, Shrigopal nagar, 80 Feet Road, Gopalpura byepass, Jaipur
Jaipur
RAJASTHAN |
9829014996
drsomani@somexresearch.com |
| Dr Cecil Ross |
St Johns Medical Institute |
Sarjapur road,-560034
Bangalore
KARNATAKA |
9448493705
cecilross@bsnl.in |
| Dr Devanand Jhanardhan |
Swapnil Apartments |
Abhyankar Road,Dhantoli-440 012
Nagpur
MAHARASHTRA |
09823012851
shriramkane@gmail.com |
| Dr. Apurva M. Sheth |
Vedanta Institute of Medical Sciences |
15, Dr G Deshmukh Marg,Near Samved Hospital, Commerce College road,-380009
Ahmadabad
GUJARAT |
09879003936
sandip60@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| EC Manipal Hospital and Manipal Heart Foundation, Dr Poonam Patil |
Approved |
| Ethics Committee, The Heart Care Clinic, Dr Apurva Sheth |
Approved |
| HCG Central Ethics Committee, Dr Radheshyam Naik |
Approved |
| Hirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development Centre Ethics Committee, Dr Shona Nag |
Approved |
| Independent Ethics Committee Dr Shriram Kane, Nagpur |
Approved |
| Independent Ethics Committee, Apollo Hospital, Dr Devanand |
Approved |
| Independent Ethics Committee, Dr Bapsy |
Approved |
| Institutional Ethics Committee, Dr Minish Jain |
Approved |
| Sanchetee Hospital & Cancer Institute Ethical Committee, Dr Suresh Sanchetee |
Approved |
| SoMex Research and Health Ethics Committee |
Approved |
| St Johns Medical College & Hospital Institution Ethical Review Board, Dr Cecil Ross |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
NONMYELOID MALIGNANCIES RECEIVING MYELOSUPPRESSIVE
CHEMOTHERAPY, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Peg G-CSF |
NA |
| Comparator Agent |
Recombinant human G-CSF |
Inj. Neupogen |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion:
The subjects included in the study should satisfy the inclusion criteria enlisted
below
1. Adult subject of either sex between age group of 18 to 65 years with histologically confirmed non myeloid malignant tumors undergoing a variety
of myelosuppressive chemotherapy regimens
2. Cancer subject with a good performance status (ECOG grade 0-2)
3. Subjects with ≥ 20% risk of developing chemotherapy induced febrile neutropenia. Subjects receiving chemotherapy regimens with intermediate to high risk for febrile
neutropenia are eligible.
4. No serious abnormality of hepatic or renal function at screening.
5. Subject willing to sign the “Informed Consent Formâ€
Exclusion:
The following categories of subjects will be excluded from the study.
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. Subject with body weight < 45 kg
3. Current therapy with other investigational drugs or lithium.
4. History or clinical evidence of congestive heart failure.
5. Prior treatment with interferons, interleukins or colony stimulating factors
(including G-CSF, GM- CSF, M-CSF and erythropoietin).
6. Subject who has been receiving radiation therapy within 4 weeks of randomization into the study.
7. Prior bone marrow or stem cell transplantation
8. Pregnant women, nursing women and women not practicing effective contraception.
9. Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication. |
|
| 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. Subject with body weight < 45 kg
3. Current therapy with other investigational drugs or lithium.
4. History or clinical evidence of congestive heart failure (NYHA class III-IV).
5. Prior treatment with interferons, interleukins, or, colony stimulating factors
(including G-CSF, GM- CSF, M-CSF and erythropoietin).
6. Subject who has been receiving radiation therapy within 4 weeks of
randomization into the study.
7. Prior bone marrow or stem cell transplantation
8. Pregnant women, nursing women and women not practicing effective contraception.
9. Subject with known hypersensitivity to E-coli derived proteins or any
component of the study medication. |
|
Method of Generating Random Sequence
Modification(s)
|
Other |
Method of Concealment
Modification(s)
|
Other |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The primary efficacy end point will be the duration in days of the grade IV
neutropenia (defined as ANC ≤ 500 /mm3) in the present chemotherapy
cycle. |
10 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
The secondary efficacy will be determined in terms of the following
secondary end points:
1. Incidence of febrile neutropenia
2. Incidence of intravenous antibiotic administration
3. Incidence of hospitalization |
10 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
02/02/2010 |
| 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
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Phase III, multicentric, randomized, open label, comparative study to compare the efficacy and safety of recombinant human pegylated granulocyte colony stimulating factor (Peg G-CSF) versus granulocyte colony stimulating factor (G-CSF) in subjects with nonmyeloid malignancies receiving myelosuppressive chemotherapy. Planned to be carried out in 11 centers, enrolling 108 subjects, this is to get a minimum of 88 evaluable subjects from seven centers. For each subject, the maximum duration of therapy with the study medication will be 10 days. |