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

Plain-language summary

This study looked at the efficacy and safety of a drug called Olaparib in Indian patients with ovarian cancer or metastatic breast cancer. To join, women had to be 18 or older; those with ovarian cancer had responded to platinum-based chemotherapy, and those with breast cancer carried a BRCA gene mutation. The study was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

AstraZeneca

Intervention

Olaparib

Start date

5/25/2020

Estimated completion

9/30/2022

Countries

India

Related genes

Locations

• Ahmedabad, India
• Bhubaneswar, India
• Chandigarh, India
• Delhi, India
• Faridabad, India
• Guwahati, India
• Kochi, India
• Kolkata, India
• Kolkata, India
• Madurai, India
• Mumbai, India
• Mumbai, India
• New Delhi, India
• New Delhi, India
• New Delhi, India
• Vellore, India

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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