Clinical trial NCT04330040: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cancer
Breast Cancer
Keywords: Ovarian Cancer; Breast Cancer, Olaparib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-04-01
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Prospective, Multicentre, Phase-IV Clinical Trial
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: Haematology: Basophils Absolute Count, Eosinophils Absolute Count, Leucocytes WBC, Lymphocytes Absolute Count, Monocytes Absolute Count, Neutrophils Absolute Count, and Platelets Parameters
timeFrame: Baseline to EOT (approximately 6 months)
measure: Haematology: Haemoglobin Parameters
timeFrame: Baseline to EOT (approximately 6 months)
measure: Number of Participants Who Experienced a Shift in Hematology Parameters to Results Classified as Below Normal at EOT
timeFrame: Baseline to EOT (approximately 6 months)
measure: Number of Participants Who Experienced a Shift in Hemoglobin Parameters to Results Classified as Below Normal at EOT
timeFrame: Baseline to EOT (approximately 6 months)
measure: Number of Participants With Remarkable Changes in Clinical Chemistry Values Over Time as Assessed by Investigator
timeFrame: Baseline to EOT (approximately 6 months)
measure: Number of Participants With Remarkable Changes in Physical Examination Over Time as Assessed by Investigator
timeFrame: Baseline to EOT (approximately 6 months)
measure: Number of Participants With Remarkable Changes in Vital Signs Over Time as Assessed by Investigator
timeFrame: Baseline to EOT (approximately 6 months)
measure: WHO Performance Status
timeFrame: Baseline and End of study visit (200 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Research Site
city: Bhubaneswar
country: India
facility: Research Site
city: Chandigarh
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Faridabad
country: India
facility: Research Site
city: Guwahati
country: India
facility: Research Site
city: Kochi
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Madurai
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Vellore
country: India
facility: Research Site
Study officials:
References: