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

Phase 4

Completed

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2020/03/024196
• Lead Sponsor: AstraZeneca Pharma India Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-04-17
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Informed consent

1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.

3. Subjects = 18 years of age

Type of subject and disease characteristics

4. 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

5. 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

Sex

6. Only Females will be recruited

Reproduction

7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential at least 72 hours prior to beginning treatment.

8. Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and through 120 days after the last dose of trial treatment.

Organ function

9. Have adequate organ function as defined in Table X. Specimens must be collected within 10 days prior to the start of trial treatment.

Hematological

Absolute neutrophil count (ANC)=1500/µL

Platelets=100,000/µL

Hemoglobin=9.0 g/dL or =5.6 mmol/L

Renal

Creatinine OR Mesaured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl)=1.5 x ULN OR

=30 ml/min for subject with creatinine levels

>1.5 x institutional ULN

Hepatic

Total bilirubin=1.5 x ULN OR direct bilirubin =ULN for subjects with total bilirubin levels >1.5 x ULN

AST (SGOT) and ALT (SGPT)=2.5 x ULN OR

=5 x ULN for subjects with liver metastases

Coagulation

International normalized ratio (INR) or prothrombin time (PT)

Activated partial thromboplastin time (aPTT)=1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Exclusion Criteria

Medical conditions

1. Subjects 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 OR

2. pregnant and/or lactating women OR

3. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis OR

4. Patients who have not recovered sufficiently from prior surgery or anticancer treatment OR

5. Patients who have known history of hepatitis B or hepatitis C OR

6. Patients with active infection such as TB

Prior/concurrent clinical study experience

7. Participation in another clinical study with a study drug administered in the last 3 months

Other exclusions

8. Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.

9. Previous enrolment in the present study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the safety of olaparib in Indian subjects with platinum sensitive relapsed ovarian cancer who are in complete or partial response following platinum-based chemotherapy, and <br/ ><br>HER – 2 negative metastatic breast cancer with germline BRCA1/2 mutation. <br/ ><br>Timepoint: End of the study period (12 months) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
nilTimepoint: nil