| CTRI Number |
CTRI/2009/091/000348 [Registered on: 22/06/2009] |
| Last Modified On: |
09/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Non interventional drug study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent |
Scientific Title of Study
Modification(s)
|
Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent |
| Trial Acronym |
Not applicable |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| A6181181 |
Protocol Number |
| NCT00836745 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400 102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400 102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Pharmaceuticals India Private Limited (a subsidiary of Pfizer Inc.) , 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400 102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Limited,
Pfizer Centre, Patel Estate,
S. V. Road, Jogeshwari West,
Mumbai 400 102
|
|
Primary Sponsor
Modification(s)
|
| Name |
Pfizer |
| Address |
Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shekhar Patil |
Bangalore Institute of Oncology |
HCG Tower No. 8, P-Kalinga Rao Road,,Sampangi Ram Nagar-560027
Bangalore
KARNATAKA |
09829060128
080-40206400
sp_associates6@rediffmail.com |
| Dr. Boman Dhabhar |
BND Oncology center, Dr.Ambedkar Road |
Citipoint Hotel, Behind Citibank ATM, Dadar,T.T. (East)-400014
Mumbai
MAHARASHTRA |
02224173003
drboman@hotmail.com |
| Rajeev Bedi |
Delwin Hospital |
Delwin Hospital
Chandigarh, Punjab 141402
India
Gurdaspur
PUNJAB |
91-9815855338
rajeevbedi@yahoo.co.in |
| Dr Lalit Mohan Sharma |
Dr. Lalit Mohans Clinic |
Dr. Lalit Mohans Clinic
66/188 Sector-6
Pratap Nagar
Jaipur, Rajasthan 302006
India
Jaipur
RAJASTHAN |
91-9928602244
drlalit2003@yahoo.com |
| Dr Suresh H Advani |
Jaslok Hospital & Research Center |
Dr. Deshmukh Marg, Pedder Road,-400026
Mumbai
MAHARASHTRA |
022 ? 66573333
02223515880
drshri555@hotmail.com |
| Dr. Vadavattat P. Gangadharan |
Lakeshore Hospital & Research Centre Ltd |
Dept. of Medical Oncology,,NH-47 By-pass, Maradu Nettoor,-682 304
|
919847064668
Bettygeorge_anil@hotmail.com |
| Dr Sudhir Rawal |
Rajiv Gandhi Cancer Hospital & Research Institute |
Sector V, Rohin,-110085
New Delhi
DELHI |
011 27051011
011 ? 27051037
dr_rawal@yahoo.com |
| Dr Shyam Agarwal |
Sir Gangaram Hospital |
Sir Gangaram Hospital, Rajinder nagar, New Delhi - 110060
New Delhi
DELHI |
011-25750000
drshyam_aggarwal@yahoo.com |
| Dr Madhuchandana Kar |
Subodh Mitra Cancer Hospital |
#1-B-175, Salt Lake City,,Sector 3, Bidhan Nagar I.B. Market,-700106
Kolkata
WEST BENGAL |
9830155915
madhuchandakar@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Bombay Hospital, Ethics Committee |
Approved |
| Ethics committee, Jaslok Hospital & Research |
Approved |
| Ethics committee, Subodh Mitra Cancer Hospital |
Approved |
| Ethics Committee, Sir Gangaram Hospital |
Approved |
| HCD Central Ethics committee, Bangalore |
Approved |
| Independent Ethics Committee |
Approved |
| Independent Ethics Committee for Dr DP Singh |
Approved |
| Independent Ethics Committee for Dr Lalit Mohan Sharma |
Approved |
| Independent Ethics Committee for Dr Rajeev Bedi |
Approved |
| Independent Ethics Committee, Dr Sachin Hingmire |
Approved |
| Institute review Board, Rajiv Gandhi Cancer Hospital & Research Institute |
Approved |
| Lake Shore Ethics committee, Lakeshore Hospital & Research Centre Ltd. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Advanced Renal Cell Carcinoma , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Sutent capsule |
Per the product information of Sutent®, the recommended starting dose of sunitinib is one 50 mg dose orally, taken daily for 4 consecutive weeks, followed by a 2-week off period (Schedule 4/2) to comprise a complete cycle of 6 weeks.
The dose is to be adjusted according to individual patient tolerance and concomitant medications.
Patients will be followed up for one year from the start of the first dose of Sutent® or till the occurrence of any of the following events signifying treatment failure, whichever occurs earlier:
1.Disease Progression .
2. Early Discontinuation of Sutent® therapy (due to unacceptable toxicity, patient’s request or lost to follow up)
3. Death
This is Non intervention trial: The assignment of the patient to Sutent® treatment is not decided in advance by this noninterventional study protocol, but falls within current practice. The decision to prescribe Sutent® is clearly not driven by the decision to include the patient in this study.
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample
Study Population
All patients with advanced renal cell cancer in the treatment naïve or cytokine refractory settings prescribed Sutent® will be eligible for the study.
Criteria
Inclusion Criteria:
Patients with advanced renal cell cancer, Treatment naïve or cytokine refractory
|
|
| ExclusionCriteria |
| Details |
Patients presenting with a known hypersensitivity to sunitinib or its metabolites
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Progression Free Survival |
1 year |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Safety and tolerability |
1 year |
| Objective response rate |
1 year |
| Management of skin & subcutaneous tissue related adverse events |
1 year |
| Management of all other adverse events |
1 year |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
21/03/2009 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.
Prospective, multi-center, non-interventional, non-comparative (single arm) study.
As of 23 November 2012, 38 subjects have been enrolled in this study. The recruitment is stopped in this study.
|