Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer (SOLI)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Breast Cancer; Ovarian Cancer

Treatments: Drug: Olaparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04330040

D0816R00025

Details and patient eligibility

About

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

Full 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.

Enrollment: 202 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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202 participants in 1 patient group

Single Arm

Experimental group

Description:

Intervention: Drug: Olaparib

Treatment:

Drug: Olaparib