| CTRI Number |
CTRI/2020/03/024196 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| 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
|
|
|
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 Sajjan Rajpurohit |
Dr. B.L Kapur Memorial Hospital |
Pusa Road
New Delhi
New Delhi
DELHI |
9999660200
sajjanrajpurohit@yahoo.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 Imran Shaikh |
Kokilaben DhiruBhai Ambani Hospital and Medical Research Institute |
2nd Floor
Center for Cancer
Raosaheb Achutrao Patwardhan Marg
Four Bunglows
Andheri
400053
Mumbai
MAHARASHTRA |
9699947210
imranshaikh0401@gmail.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 Memorial Hospital |
Dr Ernest Borges Marg
Parel (E)
400012
Mumbai
MAHARASHTRA |
9869451641
sudeepgupta04@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Amrita Institute of Medical Sciences |
Approved |
| Institute Ethics Committee All India Institute Of Medical sciences |
Approved |
| institutional Ethics Commitee Rajiv Gandhi Cancer Institute |
Approved |
| Institutional Ethics Committee, Tata Medical Center, Kolkata |
Approved |
| Institutional Ethics Committee Kokilaben DhiruBhai Ambani Hospital and Medical Research Institute |
Approved |
| IRB Christian Medical College |
Approved |
| 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 |
Approved |
| Institutional Ethics Committee Meenakshi Mission Hospital and Research Centre |
Approved |
| IEC Asian Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Tata Medical Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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. |