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CTRI Number  CTRI/2020/03/024196 [Registered on: 24/03/2020] Trial Registered Prospectively
Last Modified On: 17/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Ovarian Cancer and Metastatic Breast Cancer  
Scientific Title of Study   A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA1/2 Mutation 
Trial Acronym  SOLI Study 
Secondary IDs if Any  
Secondary ID  Identifier 
D0816R00025 Version 2.0, Date: 19 October 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudeep Gupta 
Designation  Medical Oncologist  
Affiliation  Tata Memorial Hospital 
Address  Dr Ernest Borges Marg Parel

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  sudeepgupta04@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rohit K 
Designation  Study Physician 
Affiliation  AstraZeneca Pharma India Ltd 
Address  N1 Block Manyatha Tech Park
Manyatha Tech Park
Bangalore
KARNATAKA
560045
India 
Phone    
Fax    
Email  rohit.kodagali@astrazeneca.com  
 
Details of Contact Person
Public Query
 
Name  Amit Kumar 
Designation  Project Delivery Lead 
Affiliation  AstraZeneca Pharma India Ltd 
Address  Manyatha Tech Park

Bangalore
KARNATAKA
560045
India 
Phone    
Fax    
Email  amit.kumarak@astrazeneca.com  
 
Source of Monetary or Material Support  
AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore-560045 
 
Primary Sponsor  
Name  AstraZeneca Pharma India Ltd 
Address  Manyatha Tech Park Bangalore KARNATAKA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Sharma  Action Cancer Hospital  A-4 Paschim Vihar
New Delhi
DELHI 
9999379838

ajaysharma04@rediffmail.com 
Dr Ajay Gogia  AIIMS  Sri Aurobindo Marg Ansari Nagar Ansari Nagar East 110029
New Delhi
DELHI 
9013000642

ajaygogia@gmail.com 
Dr K Pavithran  Amrita Institute of Medical Sciences  Peeliyadu Road Ponekkara Edappally
Ernakulam
KERALA 
914842851234

drkpavithran@hotmail.com 
Dr Prashant Mehta  Asian Institute of Medical Sciences  Badkal Flyover Road Sec 21A Faridabad 121001
Faridabad
HARYANA 
9599460474

prashantcipher7@gmail.com 
Dr Ashish Singh  Christian Medical College  IDA Scudder Rd 632004
Vellore
TAMIL NADU 
9445659460

ashishsingh@cmcvellore.co.in 
Dr Amit Agarwal  Dr. B.L Kapur Memorial Hospital  Pusa Road New Delhi
New Delhi
DELHI 
9971611311

deepaliamit@hotmail.com 
Dr Chirag Desai  Hemato Oncology Clinic Ahmedabad Pvt Ltd  1st Floor Vedanta Institute of Medical Sciences Near Samved Hospital Stadium Commerce College Road Navrangpura Ahmedabad 380009
Ahmadabad
GUJARAT 
9824047561

chiragdesai.oncology@gmail.com 
Dr Sewanti Limaye  Kokilaben DhiruBhai Ambani Hospital and Medical Research Institute  2nd Floor Center for Cancer Raosaheb Achutrao Patwardhan Marg Four Bunglows Andheri 400053
Mumbai
MAHARASHTRA 
9619607339

sewanti@yahoo.com 
Dr Chanchal Goswami  Medica Superspeciality Hospital  127, Mukundapur, E.M.Bypass, Kolkata- 700099
Kolkata
WEST BENGAL 
9830055035

drcgoswami@gmail.com 
Dr Krishna Kumar Rathnam  Meenakshi Mission Hospital and Research Centre  Lake Area, Melur Road, Madurai - 625107
Madurai
TAMIL NADU 
9380417299

kkrathnam@gmail.com 
Dr Amit Dutta  North East Cancer Hospital and Research Institute  North East Cancer Hospital Research Institute, Assam
Dhubri
ASSAM 
9435043054

dramitduttanechri@gmail.com 
Dr Chandan K Das  PGI  Sector 12 160012
Chandigarh
CHANDIGARH 
9968846608

ckdasoncology@gmail.com 
Dr Vineet Talwar  Rajiv Gandhi Cancer Institute & Research Centre   Room No. 2262, Rajiv Gandhi Cancer Institute & Research Centre Sector 5 Rohini 110085
New Delhi
DELHI 
9810241512

drvineettalwar@yahoo.com 
Dr Ghanshyam Biswas  Sparsh Hospital and Critical Care Ltd  A/407, Saheed Nagar, Bhubaneshwar, 751007, India
Baudh
ORISSA 
9937500878

drgbiswas@gmail.com 
Dr Joydeep Ghosh  Tata Medical Center  14 MAR(EW)New Town Kolkata 700160
Kolkata
WEST BENGAL 
9167874217

dr.joydeep.ghosh@gmail.com 
Dr Sudeep Gupta  Tata Medical Center  Dr Ernest Borges Marg Parel (E) 400012
Mumbai
MAHARASHTRA 
9821298642

sudeepgupta04@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Institutional Ethics Committee Amrita Institute of Medical Sciences  Submittted/Under Review 
Institute Ethics Commitee All India Institute Of Medical sciences  Submittted/Under Review 
institutional Ethics Commitee Rajiv Gandhi Cancer Institute  Approved 
institutional Ethics Commitee Tata Memorial Hospital, Mumbai  Submittted/Under Review 
Institutional Ethics Committee, Tata Medical Center, Kolkata  Approved 
institutional Ethics Commitee Kokilaben DhiruBhai Ambani Hospital and Medical Research Institute  Approved 
IRB Christian Medical College  Submittted/Under Review 
Dr. B.L Kapur Memorial Hospital Ethics Commitee  Approved 
institutional Ethics Commitee PGIMER  Approved 
Ethics Committee of Care Institute of Medical Sciences  Approved 
Action Cancer Hospital Ethics Committee  Approved 
Sparsh Hospital IEC  Approved 
North East Cancer Hospital & Research Institute IEC  Approved 
Medica Superspeciality Hospital IEC  Submittted/Under Review 
Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Study Drug - Olaparib  Olaparib tablet, 300mg Twice Daily, Oral, Duration 182 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Informed consent
1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
3. Subjects ≥ 18 years of age
Type of subject and disease characteristics
4. Subjects receiving olaparib for the following indications in ovarian cancer:
for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
5. Subjects receiving olaparib for the following indication in breast cancer:
in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment
Sex
6. Only Females will be recruited
Reproduction
7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential at least 72 hours prior to beginning treatment.
8. Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and through 120 days after the last dose of trial treatment.
Organ function
9. Have adequate organ function as defined in Table X. Specimens must be collected within 10 days prior to the start of trial treatment.

Hematological
Absolute neutrophil count (ANC) ≥1500/µL
Platelets ≥100,000/µL
Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Renal
Creatinine OR Mesaured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 x ULN OR
≥30 ml/min for subject with creatinine levels
>1.5 x institutional ULN
Hepatic
Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5 x ULN
AST (SGOT) and ALT (SGPT) ≤2.5 x ULN OR
≤5 x ULN for subjects with liver metastases
Coagulation
International normalized ratio (INR) or prothrombin time (PT)

Activated partial thromboplastin time (aPTT) ≤1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
 
 
ExclusionCriteria 
Details  Medical conditions
1. Subjects with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug OR
2. pregnant and/or lactating women OR
3. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis OR
4. Patients who have not recovered sufficiently from prior surgery or anticancer treatment OR
5. Patients who have known history of hepatitis B or hepatitis C OR
6. Patients with active infection such as TB
Prior/concurrent clinical study experience
7. Participation in another clinical study with a study drug administered in the last 3 months
Other exclusions
8. Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
9. Previous enrolment in the present study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of olaparib in Indian subjects with platinum sensitive relapsed ovarian cancer who are in complete or partial response following platinum-based chemotherapy, and
HER – 2 negative metastatic breast cancer with germline BRCA1/2 mutation.
 
End of the study period (12 months)
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
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)
Modification(s)  
30/05/2020 
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   Nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   A Prospective, Multicentre, Phase-IV Clinical Trial of Olaparib in Indian Patients with Platinum Sensitive Relapsed Ovarian Cancer who are in Complete or Partial Response Following Platinum based Chemotherapy and Metastatic Breast Cancer with germline BRCA1/2 Mutation.This study attempts to descriptively elucidate the safety of Olaparib in Indian subjects receiving olaparib as per the Indian regulatory approved indications in India. The data obtained from the present study will help to understand the safety profile of olaparib in Indian patients. 
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