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Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03505307
Recruitment Status : Active, not recruiting
First Posted : April 23, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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"

Condition or disease
Ovarian Cancer

Detailed 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

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Lynparza Tablets 100mg, 150mg Clinical Experience Investigation (All Case Investigation) in Patients With Platinum-sensitive Relapsed Ovarian Cancer
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Olaparib




Primary Outcome Measures :
  1. Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment [ Time Frame: from baseline to 1 year ]
    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

  2. Factors which may impact incidence of ADRs related to LYMPARZA during the observation period, analysed by patient demographic characteristics [ Time Frame: from baseline to 1 year ]
    Factors which may impact incidence of ADRs, analysed by patient demographic characteristic(past medical history, and concomitant disease etc)

  3. Incidence of ADRs not expected from "Precautions for Use" of LYNPARZA JPI [ Time Frame: from baseline to 1 year ]
    To be calculated incidence of ADRs related to LYMPARZA during the observation period not expected from "Precautions for Use" of LYNPARZA JPI



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with LYNPARZA for ovarian cancer which is the indication of the drug
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505307


Locations
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Japan
Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
Ehime, Japan
Research Site
Fukui, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyogo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Iwate, Japan
Research Site
Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Mie, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Niigata, Japan
Research Site
Oita, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Saga, Japan
Research Site
Saitama, Japan
Research Site
Shiga, Japan
Research Site
Shimane, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Research Site
Yamanashi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Toshihito Nakano AstraZeneca KK

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03505307     History of Changes
Other Study ID Numbers: D0816C00019
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents