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

Breast Cancer Clinical Trial

— SOLI  

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 Details — Status: Completed

Administrative data

• NCT number: NCT04330040
• Other study ID #: D0816R00025
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Olaparib
Tablet

Locations

Country	Name	City	State
India	Research Site	Ahmedabad
India	Research Site	Bhubaneswar
India	Research Site	Chandigarh
India	Research Site	Delhi
India	Research Site	Faridabad
India	Research Site	Guwahati
India	Research Site	Kochi
India	Research Site	Kolkata
India	Research Site	Kolkata
India	Research Site	Madurai
India	Research Site	Mumbai
India	Research Site	Mumbai
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	New Delhi
India	Research Site	Vellore

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety of olaparib in Indian subjects	Number, frequency and proportion of subjects with adverse events (AEs) and serious adverse events (SAEs).	6 Months