Clinical Trials Logo
  1. Home
  2. Ovarian Cancer
  3. NCT03505307
  4. Details
NCT03505307 Clinical Trial

Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

Ovarian Cancer Clinical Trial

Official title:
Lynparza Tablets 100mg, 150mg Clinical Experience Investigation (All Case Investigation) in Patients With Platinum-sensitive Relapsed Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03505307
Other study ID # D0816C00019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 21, 2018
Est. completion date December 7, 2020

Study information
Verified date May 2022
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

[Objectives] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use. 1. ADR development in actual clinical use 2. Factors which may affect safety and efficacy 3. ADRs not expected from "Precautions for Use"

Description:

The objective of the Clinical Experience Investigation (CEI) is to collect following data to characterise safety and efficacy of LYMPARZA Tablets 100mg and 150mg (LYMPARZA) in usual post-marketing use. 1. Development of adverse drug reactions (ADRs) 2. Factors which may affect safety and efficacy of LYMPARZA 3. Development of adverse drug reactions (ADRs) unexpected from "Precautions for Use" of the LYMPARZA JPI

Recruitment information / eligibility
Status Completed
Enrollment 846
Est. completion date December 7, 2020
Est. primary completion date December 7, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2

External Links