Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer
Ovarian Cancer · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04330040 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olaparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters |
0; 0; 0; 0; 72; 12 | — |
| PRIMARY Haematology: Haemoglobin Parameters |
0; 0; 0; 0; 15; 5 | — |
| PRIMARY Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT |
13; 5; 0; 18; 8; 2 | — |
| PRIMARY Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT |
17; 11; 0; 28 | — |
| PRIMARY Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator |
0; 0; 0 | — |
| PRIMARY Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator |
0; 0; 0 | — |
| PRIMARY WHO Performance Status |
155; 38; 1; 194; 6; 0 | — |
Summary
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
Data sourced from ClinicalTrials.gov (NCT04330040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.