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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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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.

efficacy study of olaparib with paclitaxel versus paclitaxel in gastric cancer patients

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle

100mg BID oral tablet to match olaparib tablet

D0810C00039Protocol_and_Amendments_redacted_SECURE

Research Site

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

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

Age, Customized

Ataxia-Telangiectasia Mutation (ATM) protein testing

ATM status

Study Specific Characteristic

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.

The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).

Full analysis set including all randomised patients

Progression free survival (PFS) in the overall study population

The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).

Full analysis set including randomised ATM negative patients

Progression free survival (PFS) in patients with tumours defined as Homologous Recombination Deficient by loss of Ataxia-Telangiectasia Mutation (ATM) protein [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.

Overall survival (OS) in the overall study population

Overall survival (OS) in ATM negative patients

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).

Evaluable for response population - randomised patients having measurable disease at baseline.

Objective response rate (ORR) in the overall study population

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).

Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.

Objective response rate (ORR) 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)

Percentage change in tumour size at Week 8 in the overall study population

Percentage change in tumour size at Week 8 in the ATM negative patients

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

Randomised patients having global score calculated at baseline and at least one post baseline visit

Time to deterioration in Global Quality of Life (QoL) 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

Randomised patients having fatigue score calculated at baseline and at least one post baseline visit

Time to deterioration in QoL fatigue 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

Randomised patients having nausea & vomiting domain score calculated at baseline and at least one post baseline visit

Time to deterioration in QoL nausea & vomiting 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

Randomised patients having pain domain score calculated at baseline and at least one post baseline visit

Time to deterioration in QoL pain 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

Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit

Time to deterioration in QoL dysphagia 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

Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit

Time to deterioration in QoL eating restriction 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

Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit

Time to deterioration in QoL stomach pain 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

Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit

Time to deterioration in QoL reflux 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

Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit

Time to deterioration in QoL anxiety domain score in the overall study population

Overall Study

Patients of either sex, age more than 17 years with recurrent or metastatic gastric cancer that had progressed following first line therapy, a confirmed Ataxia Telangiectasia Mutation (ATM) status, Eastern Co operative Oncology Group (ECOG) performance status ≤2, normal organ and bone marrow function, and life expectancy ≥16 weeks.

Arms	Assigned Interventions
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

efficacy study of olaparib with paclitaxel versus paclitaxel in gastric cancer patients

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSR_Synopsis_D0810C00039

D0810C00039Protocol_and_Amendments_redacted_SECURE

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator