Gold

A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase 3 Study to Assess the Efficacy and Safety of Olaparib (AZD2281) in Combination With Paclitaxel, Compared to Placebo in Combination With Paclitaxel, in Asian Patients With Advanced Gastric Cancer (Including the Gastro-oesophageal Junction) Who Have Progressed Following First Line Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222339

Enrollment

100

Registered

2013-12-24

Start date

2013-10-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

investigational material(s) Generic name etc : Olaparib, Paclitaxel INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigatio

Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily. Paclitaxel:IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.

Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Advanced gastric cancer (including GEJ) that has progressed following first-line therapy. - Privision of tumour sample (from either a resection or biopsy). - At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and following up visits.

Exclusion criteria

Exclusion criteria: - More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting. - Any previous treatment with a PARP inhibitor, including olaparib. - Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for 5 years or more. - HER2 positive patients

Design outcomes

Primary

Measure	Time frame
Overall survival(OS)	—

Countries

China, Korea, Taiwan

Contacts

Public ContactKazushige Hibi

AstraZeneca KK

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026