Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

NCT03505307 | Completed

• 1 other identifier: D0816C00019
• Study Type: observational
• Target: 846
• Locations: 0 countries
• Sites: N/A

Brief Summary

\[Objectives\] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use.

1. 1.ADR development in actual clinical use
2. 2.Factors which may affect safety and efficacy
3. 3.ADRs not expected from "Precautions for Use"

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment

  To be calculated incidence of ADRs related to LYMPARZA during the observation period regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment

  from baseline to 1 year

• Factors which may impact incidence of ADRs related to LYMPARZA during the observation period, analysed by patient demographic characteristics

  Factors which may impact incidence of ADRs, analysed by patient demographic characteristic(past medical history, and concomitant disease etc)

  from baseline to 1 year

• Incidence of ADRs not expected from "Precautions for Use" of LYNPARZA JPI

  To be calculated incidence of ADRs related to LYMPARZA during the observation period not expected from "Precautions for Use" of LYNPARZA JPI

  from baseline to 1 year

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with LYNPARZA for ovarian cancer which is the indication of the drug

You may qualify if:

• Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy

Sponsors & Collaborators

• AstraZeneca: lead

Related Links

• Related Info
• redacted protocol

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Toshimitsu Tokimoto

  AstraZeneca KK

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 23, 2018
• Study Start: May 21, 2018
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.