Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

Last updated: March 21, 2024
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Stomach Cancer

Digestive System Neoplasms

Gastric Cancer

Treatment

Placebo

Paclitaxel

Olaparib

Clinical Study ID

NCT01924533
D081BC00004
  • Ages 18-99
  • All Genders

Study Summary

This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Advanced gastric cancer (including GEJ) that has progressed following first-linetherapy.
  • Patients must be ≥18 years of age. Age ≥20 if Japanese
  • Provision of tumour sample (from either a resection or biopsy).
  • At least one lesion (measurable and/or non-measurable) that can be accurately assessedby imaging (CT/MRI) at baseline and following up visits.

Exclusion

Exclusion Criteria:

  • More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapywith more than 6 month wash out period) for the treatment of gastric cancer in theadvanced setting.
  • Any previous treatment with a Polyadenosine 5'-diphosphoribose [poly-(ADP-ribose)]polymerisation (PARP) inhibitor, including olaparib.
  • Patients with second primary cancer, except: adequately treated non-melanoma skincancer, curatively treated in-situ cancer of the cervix, or other solid tumourscuratively treated with no evidence of disease for ≥5 years.
  • Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients.

Study Design

Total Participants: 525
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 03, 2013
Estimated Completion Date:
March 27, 2023

Study Description

A randomized, double-blinded, multicentre phase III study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.

Connect with a study center

  • Research Site

    Beijing, 100071
    China

    Site Not Available

  • Research Site

    Bengbu, 233060
    China

    Site Not Available

  • Research Site

    Changchun, 130000
    China

    Site Not Available

  • Research Site

    Changsha, 410013
    China

    Site Not Available

  • Research Site

    Chengdu, 610083
    China

    Site Not Available

  • Research Site

    Fuzhou, 350014
    China

    Site Not Available

  • Research Site

    Guangzhou, 510060
    China

    Site Not Available

  • Research Site

    Hangzhou, 310016
    China

    Site Not Available

  • Research Site

    Harbin, 150081
    China

    Site Not Available

  • Research Site

    Huangzhou,
    China

    Site Not Available

  • Research Site

    Nanchang, 330006
    China

    Site Not Available

  • Research Site

    Nanjing, 210002
    China

    Site Not Available

  • Research Site

    Shanghai, 200092
    China

    Site Not Available

  • Research Site

    Urumqi, 830000
    China

    Site Not Available

  • Research Site

    Wanzhou, 404000
    China

    Site Not Available

  • Research Site

    Wuhan, 430030
    China

    Site Not Available

  • Research Site

    Xian,
    China

    Site Not Available

  • Research Site

    Yangzhou, 225001
    China

    Site Not Available

  • Research Site

    Yinchuan,
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450008
    China

    Site Not Available

  • Research Site

    Chiba-shi, 260-8717
    Japan

    Site Not Available

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Site Not Available

  • Research Site

    Fukuoka-shi, 811-1395
    Japan

    Site Not Available

  • Research Site

    Kasama-shi, 309-1793
    Japan

    Site Not Available

  • Research Site

    Kashiwa-shi,
    Japan

    Site Not Available

  • Research Site

    Kawasaki-shi, 216-8511
    Japan

    Site Not Available

  • Research Site

    Kitaadachi-gun, 362-0806
    Japan

    Site Not Available

  • Research Site

    Koto-ku, 135-8550
    Japan

    Site Not Available

  • Research Site

    Matsuyama-shi, 791-0280
    Japan

    Site Not Available

  • Research Site

    Nagoya-shi, 464-8681
    Japan

    Site Not Available

  • Research Site

    Sapporo-shi, 003-0804
    Japan

    Site Not Available

  • Research Site

    Takatsuki-shi, 569-8686
    Japan

    Site Not Available

  • Research Site

    Utsunomiya-shi, 320-0834
    Japan

    Site Not Available

  • Research Site

    Yokohama-shi, 241-8515
    Japan

    Site Not Available

  • Research Site

    Anyang-si, 431-070
    Korea, Republic of

    Site Not Available

  • Research Site

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Research Site

    Hwasun-gun, 58128
    Korea, Republic of

    Site Not Available

  • Research Site

    Jeonju-si, 561-712
    Korea, Republic of

    Site Not Available

  • Research Site

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Research Site

    Kaohsiung Hsien, 83342
    Taiwan

    Site Not Available

  • Research Site

    Taichung,
    Taiwan

    Site Not Available

  • Research Site

    Tainan, 704
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 11217
    Taiwan

    Site Not Available

  • Research Site

    Tao-Yuan,
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Site Not Available

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