Gastric CancerPhase 3NCT01924533

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

A Phase 3 study testing Olaparib and Paclitaxel in people with Gastric Cancer, run by AstraZeneca at 57 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Gastric Cancer
What is being tested?: Olaparib and Paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 525 participants
Where: 57 sitesin 4 countries
Study dates: 3 Sep 2013to 27 Mar 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Advanced gastric cancer (including GEJ) that has progressed following first-line therapy.
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 assessed by imaging (CT/MRI) at baseline and following up visits.

Who cannot join

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 Polyadenosine 5'-diphosphoribose [poly-(ADP-ribose)] polymerisation (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.
Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients.

Trial locations and contacts

57 sites in 4 countries.

Country

City, postcode or hospital

57 sites in 4 countries

China26 sites

Research Site
Beijing, 100021
Research Site
Beijing, 100071
Research Site
Beijing, 100142
Research Site
Bengbu, 233060
Research Site
Changchun, 130000
Research Site
Changsha, 410005
Research Site
Changsha, 410011
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Chengdu, 610083
Research Site
Fuzhou, 350014
Research Site
Guangzhou, 510060
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310016
Research Site
Hangzhou, 310022
Research Site
Harbin, 150081
Research Site
Nanchang, 330006
Research Site
Nanjing, 210002
Research Site
Nanjing, 210009
Research Site
Shanghai, 200032
Research Site
Shanghai, 200092
Research Site
Ürümqi, 830000
Research Site
Wanzhou, 404000
Research Site
Wuhan, 430030
Research Site
Yangzhou, 225001
Research Site
Zhengzhou, 450008

Other trials in China

Japan14 sites

Research Site
Chiba, 260-8717
Research Site
Chūōku, 104-0045
Research Site
Fukuoka, 811-1395
Research Site
Kasama-shi, 309-1793
Research Site
Kawasaki-shi, 216-8511
Research Site
Kitaadachi-gun, 362-0806
Research Site
Kōtoku, 135-8550
Research Site
Matsuyama, 791-0280
Research Site
Nagoya, 464-8681
Research Site
Sapporo, 003-0804
Research Site
Sapporo, 060-8648
Research Site
Takatsuki-shi, 569-8686
Research Site
Utsunomiya, 320-0834
Research Site
Yokohama, 241-8515

Other trials in Japan

South Korea12 sites

Research Site
Anyang-si, 431-070
Research Site
Daegu, 42415
Research Site
Hwasun-gun, 58128
Research Site
Jeonju, 561-712
Research Site
Seongnam-si, 13620
Research Site
Seoul, 02841
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06273
Research Site
Seoul, 06591
Research Site
Seoul, 156-707
Research Site
Seoul, 6351

Other trials in South Korea

Taiwan5 sites

Research Site
Kaohsiung Hsien, 83342
Research Site
Taichung
Research Site
Tainan, 704
Research Site
Taipei, 11217
Research Site
Taoyuan, 333

Other trials in Taiwan

About this study

Official title: A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase III 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

Read the detailed 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.

Conditions: Gastric Cancer
Being tested: Olaparib, Paclitaxel, Placebo
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OlaparibDrug
Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.
PaclitaxelDrug
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
PlaceboDrug
Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.

Study groups in NCT01924533
Study group	Role	What they receive
Olaparib+ paclitaxel	Experimental	olaparib + paclitaxel Receives: Drug: Olaparib; Drug: Paclitaxel
Placebo+paclitaxel	Placebo comparator	placebo+ paclitaxel Receives: Drug: Paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
Time from the date of randomization until death due to any cause
Measured: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years

Secondary outcomes (6)

Progression-Free Survival (PFS)
Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.
Measured: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients With Objective Response.
Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.
Measured: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients Objective Response
Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.
Measured: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale
Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration
Measured: Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years
Time to Response
Time from randomization to the first onset of a confirmed objective tumour response
Measured: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Duration of Response
Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits
Measured: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 201327 Mar 2023

First posted16 Aug 2013 (estimated)
Study start3 Sep 2013
Primary completion4 Apr 2016
Study completion27 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 525 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01924533
Sponsor's protocol ID: D081BC00004
Status last verified: Mar 2024
First submitted: 14 Aug 2013
Last updated: 22 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, Qin S, Xu N, Im SA, Locker G, Rowe P, Shi X, Hodgson D, Liu YZ, Boku N. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1637-1651. doi: 10.1016/S1470-2045(17)30682-4. Epub 2017 Nov 2.
PubMed 29103871

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase III 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
ClinicalTrials.gov ID: NCT01924533
Acronym / sponsor ID: D081BC00004
Conditions: Gastric Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 525 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 3 Sep 2013 (actual)
Primary completion: 4 Apr 2016 (actual)
Study completion: 27 Mar 2023 (actual)
First posted: 16 Aug 2013 (estimated)
Results: Posted 7 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Olaparib+ paclitaxel	Experimental	Drug: Olaparib, Drug: Paclitaxelolaparib + paclitaxel
Placebo+paclitaxel	Placebo comparator	Drug: Paclitaxel, Drug: Placeboplacebo+ paclitaxel

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Advanced gastric cancer (including GEJ) that has progressed following first-line therapy.
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 assessed by imaging (CT/MRI) at baseline and following up visits.

Key exclusion criteria (4 listed)

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 Polyadenosine 5'-diphosphoribose [poly-(ADP-ribose)] polymerisation (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.
Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OlaparibTablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.	Drug	Olaparib+ paclitaxel
PaclitaxelIV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.	Drug	Olaparib+ paclitaxel, Placebo+paclitaxel
PlaceboTablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.	Drug	Placebo+paclitaxel

Primary outcome

Overall Survival
Time frame: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years
Time from the date of randomization until death due to any cause

6 secondary outcomes

Progression-Free Survival (PFS)
Time frame: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients With Objective Response.
Time frame: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients Objective Response
Time frame: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale
Time frame: Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years
Time to Response
Time frame: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Duration of Response
Time frame: Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years

Results and safety

Results posted to the registry on 7 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2	263	74
Placebo Tablets bd + Paclitaxel 80 mg/m^2	262	57

Primary outcome: Overall Survival

Time frame: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years. Number. Unit: participants

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n = 263	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n = 262
Value	82	62

Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 vs Placebo Tablets bd + Paclitaxel 80 mg/m^2: Hazard Ratio (HR): 0.79 (97.5% CI 0.63 to 1.00), p = 0.0262, Cox proportional hazards model

Population analysed: Full analysis set population

Primary outcome: Overall Survival

Measure	Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 n = 48	Placebo Tablets bd + Paclitaxel 80 mg/m^2 n = 46
Value	19	11

Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 vs Placebo Tablets bd + Paclitaxel 80 mg/m^2: Hazard Ratio (HR): 0.73 (97.5% CI 0.40 to 1.34), p = 0.2458, Cox proportional hazards model

Population analysed: Full analysis set - ATM negative population

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2	92 of 262 (35.1%)	257 of 262 (98.1%)	181 of 263
Placebo Tablets bd + Paclitaxel 80 mg/m^2	65 of 259 (25.1%)	253 of 259 (97.7%)	200 of 262

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29103871Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, Qin S, Xu N, Im SA, Locker G, Rowe P, Shi X, Hodgson D, Liu YZ, Boku N. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1637-1651. doi: 10.1016/S1470-2045(17)30682-4. Epub 2017 Nov 2.
Study protocol-redactedLink provided by the sponsor.
CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yung-Jue Bang, MD principal investigator

Seoul National University, College of Medicine and Cancer Research Institute, Republic of Korea

57 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olaparib and Paclitaxel in people with Gastric Cancer, run by AstraZeneca at 57 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in China, Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01924533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.