Clinical trial · Interventional
Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olaparib | Drug | Olaparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Intervention: Drug: Olaparib
- interventionNames
- Drug: Olaparib
Primary outcomes (8)
- measure
- Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
- timeFrame
- Baseline to EOT (approximately 6 months)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available