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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04330040
• Collaborator: (none)
• Enrollment: 162
• Locations: 15
• Arm: 1
• Anticipated Duration (Months): 26
• Patients Per Site: 10.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer; Breast Cancer	Drug: Olaparib	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A Prospective, Multicentre, Phase-IV Clinical TrialA Prospective, Multicentre, Phase-IV Clinical Trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 30, 2020
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm Intervention: Drug: Olaparib	Drug: Olaparib; Tablet

Outcome Measures

Primary Outcome Measures

1. To assess the safety of olaparib in Indian subjects [6 Months]

   Number, frequency and proportion of subjects with adverse events (AEs) and serious adverse events (SAEs).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Ahmedabad		India	380009
2	Research Site	Ansari Nagar		India	110 029
3	Research Site	Bhubaneswar		India	751007
4	Research Site	Chandigarh		India	160012
5	Research Site	Faridabad		India	121001
6	Research Site	Kamrup		India	781023
7	Research Site	Kochi		India	682041
8	Research Site	Kolkata		India	700099
9	Research Site	Kolkata		India	700160
10	Research Site	Madurai		India	625107
11	Research Site	Mumbai		India	400012
12	Research Site	Mumbai		India	400053
13	Research Site	New Delhi		India	110005
14	Research Site	New Delhi		India	110085
15	Research Site	Vellore		India	632004

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT04330040
• Other Study ID Numbers: D0816R00025
• First Posted: Apr 1, 2020
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AstraZeneca: Ovarian Cancer; Breast Cancer, Olaparib
• Additional relevant MeSH terms: Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Olaparib

Study Results

No Results Posted as of Jul 12, 2022