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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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The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy

Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian cancer

CTIS Number

EudraCT Number

NCT ID

Patient Level Data

Therapeutic Area

Cancer Study Locator (US and Canada only)

Research Site

Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive relapsed  serous ovarian cancer following treatment with two or more platinum containing regimens

PFS was defined as the time from randomisation to the earlier date
of radiological progression (per RECIST criteria) or death by any
cause in the absence of objective progression. [Full analysis set
(FAS)]

Age Continuous

Gender, Male/Female

The time to disease progression from the completion of the penultimate platinum containing therapy (last dose) prior to enrolment on the study.

Time to progression

Study Specific Characteristic

Objective response to the last platinum containing regimen prior to enrolment on the study: 
-CR-Complete Response (defined as normal radiological findings and CA-125 within the normal range)
-PR-Partial Response (defined as a RECIST PR and/or GCIG CA-125 response)

Objective response

For OM DoR: The subset of patients evaluable for response who responded to study treatment.Values in results table may be under-estimates as some patients had not progressed at final analysis,so true duration is likely to be greater than in database.

PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]

Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])

OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.

Overall Survival (OS)

For each treatment group, the ORR was the number of Complete
Response (CR) and Partial Response (PR) divided by the number of
patients in the group in the FAS with measurable disease at baseline
(displayed as a percentage below). Evaluable for response set

Evaluable for response set - A subset of the full analysis set which includes patients with
measurable disease at baseline

Objective Response Rate (ORR) (According to RECIST)

Disease control rate was defined as the percentage of patients who
have at least 1 confirmed visit response of CR or PR or have
demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1
week) prior to any evidence of progression. [FAS]

Disease Control Rate

Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn.

Duration of Response

Percentage change from baseline to Week 24 in target tumour size.

Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.

Percentage Change From Baseline in Tumour Size at Week 24

Best percentage change from baseline in CA-125 level

A subset of the FAS with baseline and at least 1 follow-up value of CA-125

Best Percentage Change in Cancer Antigen 125 (CA-125) Levels

Complete Response

Partial Response

No evidence of disease

Stable Disease >= 11 weeks

Disease Progression

Not Evaluable

Best overall response from radiologic assessments. [FAS]

Best Objective Response

RECIST Response

Confirmed RECIST Response

Unconfirmed RECIST response

CA-125 Response

Confirmed RECIST or CA-125 Response

RECIST and CA-125 response separately and combined [Patients
evaluable for either CA-125 response or RECIST response]

RECIST and CA-125 Response Separately and Combined

Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]

Time to Earlier of CA-125 or RECIST Progression

The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than
or equal to +3. [Evaluable for FOSI set]

Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline

Improvement Rate for FACT-O Symptom Index (FOSI)

The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]

Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline

Improvement Rate for Trial Outcome Index (TOI)

The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]

Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline

Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)

The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]

FACT-O Symptom Index (FOSI) Time to Worsening

The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]

Trial Outcome Index(TOI)Time to Worsening

The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]

Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening

Overall Study

It was planned that 250 women with advanced platinum sensitive serous ovarian cancer who
had received 2 or more previous platinum-containing regimens and demonstrated an objective
stable maintained response in the last platinum regimen prior to enrolment were to receive
olaparib 400 mg bd or matching placebo in a 1:1 ratio. 265 randomised.

Global Clinical Lead

OS = time from randomisation to date of death from any cause.
Patients who had not died at time of analysis were censored at last
date patient was known to be alive. [FAS]
There were insufficient events to calculate median OS or perform formal statistical analysis so percentage of patients who died are shown along with 95% confidence intervals.

Duration of response = time from assessment prior to timepoint
where PR or CR confirmed (i.e. initial assessment of PR/CR), until
earliest date of objective progression or death. [Responding patients
only].

Time from randomisation to the earlier date of radiological
progression (per RECIST criteria) or CA-125 or death by any cause
in the absence of objective progression. [FAS]

The time to worsening was compared between treatments for each
of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]

The time to worsening was compared between treatments for each
of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]

The time to worsening was compared between treatments for each
of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]

Arms	Assigned Interventions
Experimental: 1 AZD2281	Drug: AZD2281 Tablets Oral BID Other Name: Olaparib, Lynparza
Placebo Comparator: 2 matching placebo	Drug: matching placebo matching placebo bid

Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian cancer

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

Cancer Study Locator (US and Canada only)

CSR_Synospsis-D0810C00019.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator