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

Sponsor
AstraZeneca
Study ID
NCT04330040
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
May 25, 2020
Status verified
Feb 2025
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022

Study Design

Enrollment
202 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Intervention: Drug: Olaparib

Primary Outcome Measure

Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters [ Time Frame: Baseline to EOT (approximately 6 months) ]

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