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CTRI Number  CTRI/2012/03/002483 [Registered on: 07/03/2012] Trial Registered Prospectively
Last Modified On: 21/07/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Evaluate the effect of Metformin versus Placebo as an Add-on Therapy in patients with recurrent epithelial ovarian cancer receiving chemotherapy: A double blind randomized controlled clinical trial.  
Scientific Title of Study   To Evaluate the effect of Metformin versus Placebo as an Add-on Therapy in patients with recurrent epithelial ovarian cancer receiving chemotherapy: A double blind randomized controlled clinical trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saphalta Baghmar 
Designation  Senior Resident 
Affiliation   
Address  Department of Medical Oncology Dr. Bhim Rao Ambedkar Institute and Rotrary Cancer Hospital, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9811446828  
Fax    
Email  drbsaphalta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saphalta Baghmar 
Designation  Senior Resident 
Affiliation   
Address  Department of Medical Oncology Dr. Bhim Rao Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9811446828  
Fax    
Email  drbsaphalta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Saphalta Baghmar 
Designation  Senior Resident 
Affiliation   
Address  Department of Medical Oncology Dr. Bhim Rao Ambedkar Institute Rotary Cancer Hospital, New Delhi

South
DELHI
110029
India 
Phone  9968125074  
Fax    
Email  drbsaphalta@gmail.com  
 
Source of Monetary or Material Support  
Dr Reddys Laboratories Ltd. 
 
Primary Sponsor  
Name  Dr Reddys Laboratories Ltd 
Address  6-3-1192/1/1, Block I 5th Floor, White House Kundanbagh, Begumpet Hyderabad, A.P. � 500016 Tel- 040-66022500 � 08  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lalit Kumar  AIIMS  Department of Medical Oncology Dr. BRA IRCH, AIIMS, New Delhi
South
DELHI 
9811446828

lalitaiims@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Ethics committee, AIIMS New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Recurrent Epithelial Ovarian Cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  metformin   Dose - 500 mg twice daily orally for one year  
Comparator Agent  placebo(starch powder)  Dose - 500 mg twice daily orally for one year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Patients of recurrent epithelial ovarian cancer
Age more than 18 years and up to 70 years
 
 
ExclusionCriteria 
Details  Patient with diabetes mellitus
Patients who have received metformin or another mTOR inhibitor in the last 2 years
Patients with deranged liver or renal profile
Patients with known hypersensitivity to metformin
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
prolonging progression free survival  patients will be followed for 1 year and time to relapse will be noted 
 
Secondary Outcome  
Outcome  TimePoints 
i) To evaluate response rate in two arms
ii) To study the toxicity profile in two groups
iii) To evaluate overall survival in two groups
iv) To compare the Quality of life between two groups
 
1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   07/03/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Brief Summary   Patients with recurrent epithelial ovarian cancer undergoing chemotherapy  will be randomized either to metformin or placebo arm 
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