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 Chemotherapy and Metastatic Breast Cancer with germline BRCA (BReast CAncer
gene) 1/2 Mutation
Title
- Brief Title: Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
D0816R00025
- NCT ID:
NCT04330040
Conditions
- Ovarian Cancer
- Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
Olaparib | | Single Arm |
Purpose
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
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 Chemotherapy and Metastatic Breast Cancer with germline BRCA(BReast CAncer
gene)1/2 Mutation As per recommendation from DCGI(Drug Controller general of of India), the
current phase-IV study is planned with the aim to assess the safety in Indian subjects
receiving olaparib as per the approved label indications in India in accordance with the
requirements of the Health Authorities of India. This study attempts to descriptively
elucidate the safety of Olaparib in Indian subjects receiving olaparib as per the Indian
regulatory approved indications in India. The data obtained from the present study will help
to understand the safety profile of olaparib in Indian patients.
Trial Arms
Name | Type | Description | Interventions |
---|
Single Arm | Experimental | Intervention: Drug: Olaparib | |
Eligibility Criteria
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
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | To assess the safety of olaparib in Indian subjects |
Time Frame: | 6 Months |
Safety Issue: | |
Description: | Number, frequency and proportion of subjects with adverse events (AEs) and serious adverse events (SAEs). |
Details
Phase: | Phase 4 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AstraZeneca |
Trial Keywords
- Ovarian Cancer; Breast Cancer, Olaparib
Last Updated
July 23, 2021