Status:
COMPLETED
Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Ovarian Cancer
Breast Cancer
Eligibility:
FEMALE
18-99 years
Phase:
PHASE4
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 Chem...
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 Chem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04330040
Start Date
May 25 2020
End Date
September 30 2022
Last Update
March 10 2025
Active Locations (16)
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1
Research Site
Ahmedabad, India, 380009
2
Research Site
Bhubaneswar, India, 751007
3
Research Site
Chandigarh, India, 160012
4
Research Site
Delhi, India, 110029