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Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

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ClinicalTrials.gov Identifier: NCT01063517
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : April 30, 2015
Last Update Posted : July 20, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: olaparib Drug: paclitaxel Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2010
Actual Primary Completion Date : May 11, 2012
Actual Study Completion Date : June 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Olaparib + paclitaxel
 Drug: olaparib
100mg BID oral tablet continuous

Drug: paclitaxel
iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
Other Name: Taxol
Active Comparator: 2
paclitaxel + placebo
 Drug: paclitaxel
iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
Other Name: Taxol

Drug: Placebo
100mg BID oral tablet to match olaparib tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 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.

  2. 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 ]
    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.

  3. 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 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).

  4. 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 ]
    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).

  5. 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 from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)

  6. Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients [ Time Frame: Tumour scans done at Baseline and week 8 ]
    Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)

  7. 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 calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

  8. 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 calculated from randomisation till worsening of fatigue score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

  9. 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 calculated from randomisation till worsening of nausea & vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

  10. 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 calculated from randomisation till worsening of pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

  11. 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 calculated from randomisation till worsening of dysphagia domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

  12. 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 calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

  13. 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 calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

  14. 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 calculated from randomisation till worsening of reflux domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

  15. 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 ]
    Time calculated from randomisation till worsening of anxiety domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT01063517


Locations
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Korea, Republic of
Research Site
Goyang-si, Korea, Republic of, 410-769
Research Site
Jeonnam, Korea, Republic of, 519-763
Research Site
Seoul, Korea, Republic of, 03722
Research Site
Seoul, Korea, Republic of, 110-744
Research Site
Seoul, Korea, Republic of, 134-791
Research Site
Seoul, Korea, Republic of, 137-701
Research Site
Taegu, Korea, Republic of, 705-035
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Yung-Jue Bang, MD Seoul National University Hospital
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01063517    
Other Study ID Numbers: D0810C00039
First Posted: February 5, 2010    Key Record Dates
Results First Posted: April 30, 2015
Last Update Posted: July 20, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by AstraZeneca:
Poly(ADP ribose)
polymerase (PARP)
Gastric cancer
olaparib
PARP inhibitor
 ATM AZD2281
Ku0059436
Homologous Recombination deficiency (HRD)
Recurrent gastric cancer
metastatic gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
 Olaparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors