Clinical Trials /

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

NCT04330040

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

Related Conditions:
  • Breast Carcinoma
  • Fallopian Tube Carcinoma
  • Malignant Ovarian Epithelial Tumor
  • Primary Peritoneal Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 4

Trial Eligibility

Document

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

DrugSynonymsArms
OlaparibSingle 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

NameTypeDescriptionInterventions
Single ArmExperimentalIntervention: Drug: Olaparib
  • 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:N/A
Minimum Eligible Age:N/A
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:Not yet recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Ovarian Cancer; Breast Cancer, Olaparib

Last Updated

March 30, 2020