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

February 19, 2025 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Ahmedabad, India, 380009
        • Research Site
      • Bhubaneswar, India, 751007
        • Research Site
      • Chandigarh, India, 160012
        • Research Site
      • Delhi, India, 110029
        • Research Site
      • Faridabad, India, 121001
        • Research Site
      • Guwahati, India, 781023
        • Research Site
      • Kochi, India, 682041
        • Research Site
      • Kolkata, India, 700160
        • Research Site
      • Kolkata, India, 700099
        • Research Site
      • Madurai, India, 625107
        • Research Site
      • Mumbai, India, 400053
        • Research Site
      • Mumbai, India, 400012
        • Research Site
      • New Delhi, India, 110063
        • Research Site
      • New Delhi, India, 110 085
        • Research Site
      • New Delhi, India, 110005
        • Research Site
      • Vellore, India, 632004
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Intervention: Drug: Olaparib
Drug: Olaparib
Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
Time Frame: Baseline to EOT (approximately 6 months)

The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. Comparison between the cohorts was not the objective for the study. The hematology data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population .

EOT = end of treatment
Baseline to EOT (approximately 6 months)
Haematology: Haemoglobin Parameters
Time Frame: Baseline to EOT (approximately 6 months)

The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib. The haemoglobin parameter data were analyzed as above normal/normal/below normal and are presented as end of treatment status for the overall population .

EOT = end of treatment
Baseline to EOT (approximately 6 months)
Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
Time Frame: Baseline to EOT (approximately 6 months)

The number of participants who experienced hematology results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented.

The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.

EOT = end of treatment
Baseline to EOT (approximately 6 months)
Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT
Time Frame: Baseline to EOT (approximately 6 months)

The number of participants who experienced hemoglobin results classified as normal at Baseline which shifted to below normal at the End of Treatment visit are presented..

The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.

EOT = end of treatment
Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator
Time Frame: Baseline to EOT (approximately 6 months)

The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.

Remarkable changes were assessed by the investigator.

EOT = end of treatment
Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
Time Frame: Baseline to EOT (approximately 6 months)

Abnormal clinically significant results at Baseline and EOT are presented.

The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Baseline to EOT (approximately 6 months)
Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator
Time Frame: Baseline to EOT (approximately 6 months)

The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.

Remarkable changes were assessed by the investigator.

EOT = end of treatment
Baseline to EOT (approximately 6 months)
WHO Performance Status
Time Frame: Baseline and End of study visit (200 days)
The objective of this Phase 4 study was to assess the overall safety of Olaparib in participants with ovarian or breast cancer who were prescribed the drug in routine clinical practice based on locally approved prescribing information. The number of participants with ovarian or breast cancer planned to receive Olaparib was not predetermined and was dependent on patients in routine clinical practice eligible to receive Olaparib.
Baseline and End of study visit (200 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0816R00025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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