Gastric CancerPhase 2NCT01063517
Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients
A Phase 2 study testing olaparib and paclitaxel in people with Gastric Cancer, run by AstraZeneca at 7 sites in South Korea.
Trial summary
To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 130 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
- 124 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 2 Feb 2010to 29 Jun 2023
- Phase
- Phase 2
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent or metastatic gastric cancer that has progressed following first line-therapy
- Confirmed ATM protein status by IHC archival tumour sample
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and follow up visits
Who cannot join
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Research Site
Goyang-si, 410-769
Research Site
Jeonnam, 519-763
Research Site
Seoul, 03722
Research Site
Seoul, 110-744
Research Site
Seoul, 134-791
Research Site
Seoul, 137-701
Research Site
Taegu, 705-035
About this study
Official title: A Randomised, Double Blinded, Multicentre Phase II Study to Assess the Efficacy of Olaparib (AZD2281, KU-0059436) in Combination With Paclitaxel Versus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.
- Conditions
- Gastric Cancer
- Being tested
- olaparib, paclitaxel, Placebo
- Keywords
- Poly(ADP ribose), polymerase (PARP), Gastric cancer, olaparib, PARP inhibitor, ATM AZD2281, Ku0059436, Homologous Recombination deficiency (HRD), Recurrent gastric cancer, metastatic gastric cancer
- 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
100mg BID oral tablet continuous
paclitaxelDrug
Also called Taxol
iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
PlaceboDrug
100mg BID oral tablet to match olaparib tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olaparib + paclitaxel Receives: Drug: olaparib; Drug: paclitaxel |
| 2 | Active comparator | paclitaxel + placebo Receives: Drug: paclitaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) in the Overall Study Population
PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.
Measured: Tumour assessments were carried out 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 maximum up to 27 months
Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]
PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.
Measured: Tumour assessments are carried out 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 maximum up to 27 months
Secondary outcomes (15)
Overall Survival (OS) in the Overall Study Population
Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.
Measured: Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months
Overall Survival (OS) in ATM Negative Patients
Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.
Measured: Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months
Objective Response Rate (ORR) in the Overall Study Population
Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Measured: Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months
Objective Response Rate (ORR) in the ATM Negative Patients
Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Measured: Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months
Percentage Change in Tumour Size at Week 8 in the Overall Study Population
Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)
Measured: Tumour scans done at Baseline and week 8
Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients
Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)
Measured: Tumour scans done at Baseline and week 8
Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population
Time calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Fatigue Score in the Overall Study Population
Time calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population
Time calculated from randomisation till worsening of nausea \& vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Pain Domain Score in the Overall Study Population
Time calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population
Time calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population
Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population
Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population
Time calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population
Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data
Measured: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study start2 Feb 2010
- Primary completion11 May 2012
- Study completion29 Jun 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jane Robertson, BSc, MBCHB, MD, Study director, AstraZenecaYung-Jue Bang, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063517
- Sponsor's protocol ID
- D0810C00039
- Status last verified
- Jul 2023
- First submitted
- 4 Feb 2010
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
Chan KH, Rutazanaa D, Wray C, Thosani N, Yang V, Cen P. Promising Response of Olaparib in Patient With Germline ATM-Mutated Metastatic Gastric Cancer. J Investig Med High Impact Case Rep. 2024 Jan-Dec;12:23247096241240176. doi: 10.1177/23247096241240176.
PubMed 38504422
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blinded, Multicentre Phase II Study to Assess the Efficacy of Olaparib (AZD2281, KU-0059436) in Combination With Paclitaxel Versus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
- ClinicalTrials.gov ID
- NCT01063517
- Acronym / sponsor ID
- D0810C00039
- Conditions
- Gastric Cancer
- Keywords
- Poly(ADP ribose), polymerase (PARP), Gastric cancer, olaparib, PARP inhibitor, ATM AZD2281, Ku0059436, Homologous Recombination deficiency (HRD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2010 (actual)
- Primary completion
- 11 May 2012 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Posted 30 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.
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 |
|---|---|---|
| 1 | Experimental | Drug: olaparib, Drug: paclitaxelOlaparib + paclitaxel |
| 2 | Active comparator | Drug: paclitaxel, Drug: Placebopaclitaxel + placebo |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent or metastatic gastric cancer that has progressed following first line-therapy
- Confirmed ATM protein status by IHC archival tumour sample
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and follow up visits
Key exclusion criteria (3 listed)
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent 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
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 |
|---|---|---|
| olaparib100mg BID oral tablet continuous | Drug | 1 |
| paclitaxelAlso: Taxoliv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle | Drug | 1, 2 |
| Placebo100mg BID oral tablet to match olaparib tablet | Drug | 2 |
Primary outcome
Progression Free Survival (PFS) in the Overall Study Population
Time frame: Tumour assessments were carried out 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 maximum up to 27 months
PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.
Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]
Time frame: Tumour assessments are carried out 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 maximum up to 27 months
PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.
15 secondary outcomes
Overall Survival (OS) in the Overall Study Population
Time frame: Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months
Overall Survival (OS) in ATM Negative Patients
Time frame: Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months
Objective Response Rate (ORR) in the Overall Study Population
Time frame: Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months
Objective Response Rate (ORR) in the ATM Negative Patients
Time frame: Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months
Percentage Change in Tumour Size at Week 8 in the Overall Study Population
Time frame: Tumour scans done at Baseline and week 8
Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients
Time frame: Tumour scans done at Baseline and week 8
Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Fatigue Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Pain Domain Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population
Time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38504422Chan KH, Rutazanaa D, Wray C, Thosani N, Yang V, Cen P. Promising Response of Olaparib in Patient With Germline ATM-Mutated Metastatic Gastric Cancer. J Investig Med High Impact Case Rep. 2024 Jan-Dec;12:23247096241240176. doi: 10.1177/23247096241240176.
- CSR\_Synopsis\_D0810C00039Link provided by the sponsor.
- D0810C00039Protocol\_and\_Amendments\_redacted\_SECURELink 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.
Jane Robertson, BSc, MBCHB, MD study director
AstraZeneca
Yung-Jue Bang, MD principal investigator
Seoul National University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing olaparib and paclitaxel in people with Gastric Cancer, run by AstraZeneca at 7 sites in South Korea.
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 3 inclusion and 3 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Apr 2015). 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?
Progression Free Survival (PFS) in the Overall Study Population (time frame: Tumour assessments were carried out 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 maximum up to 27 months). The study lists 2 primary outcomes in all. 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 NCT01063517, 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 20 Jul 2023.