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Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer (SOLI)

Primary Purpose

Ovarian Cancer, Breast Cancer

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Olaparib
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer; Breast Cancer, Olaparib

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures..
  2. Female Subjects with ≥ 18 years of age

  3. 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

  4. 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

Exclusion Criteria:

  1. Patients 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.
  2. pregnant and/or lactating women.
  3. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis.
  4. Patients who have not recovered sufficiently from prior surgery or anticancer treatment.
  5. Patients who have known history of hepatitis B or hepatitis C
  6. Patients with active infection such as TB.
  7. Participation in another clinical study with a study drug administered in the last 3 months

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Intervention: Drug: Olaparib

Outcomes

Primary Outcome Measures

To assess the safety of olaparib in Indian subjects
Number, frequency and proportion of subjects with adverse events (AEs) and serious adverse events (SAEs).

Secondary Outcome Measures

Full Information

First Posted
March 30, 2020
Last Updated
October 28, 2022
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04330040
Brief Title
Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer
Acronym
SOLI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 BRCA (BReast CAncer gene) 1/2 Mutation
Detailed Description
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 BRCA(BReast CAncer gene)1/2 Mutation As per recommendation from DCGI(Drug Controller general of of India), the current phase-IV study is planned with the aim to assess the safety in Indian subjects receiving olaparib as per the approved label indications in India in accordance with the requirements of the Health Authorities of India. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Breast Cancer
Keywords
Ovarian Cancer; Breast Cancer, Olaparib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
A Prospective, Multicentre, Phase-IV Clinical Trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Intervention: Drug: Olaparib
Intervention Type
Drug
Intervention Name(s)
Olaparib
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
To assess the safety of olaparib in Indian subjects
Description
Number, frequency and proportion of subjects with adverse events (AEs) and serious adverse events (SAEs).
Time Frame
6 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures.. Female Subjects with ≥ 18 years of age 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 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 Exclusion Criteria: Patients 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. pregnant and/or lactating women. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis. Patients who have not recovered sufficiently from prior surgery or anticancer treatment. Patients who have known history of hepatitis B or hepatitis C Patients with active infection such as TB. Participation in another clinical study with a study drug administered in the last 3 months
Facility Information:
Facility Name
Research Site
City
Ahmedabad
ZIP/Postal Code
380009
Country
India
Facility Name
Research Site
City
Bhubaneswar
ZIP/Postal Code
751007
Country
India
Facility Name
Research Site
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Research Site
City
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Research Site
City
Faridabad
ZIP/Postal Code
121001
Country
India
Facility Name
Research Site
City
Guwahati
ZIP/Postal Code
781023
Country
India
Facility Name
Research Site
City
Kochi
ZIP/Postal Code
682041
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700099
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700160
Country
India
Facility Name
Research Site
City
Madurai
ZIP/Postal Code
625107
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400053
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110 085
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110005
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110063
Country
India
Facility Name
Research Site
City
Vellore
ZIP/Postal Code
632004
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer

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