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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00753545
Recruitment Status : Active, not recruiting
First Posted : September 16, 2008
Results First Posted : March 11, 2013
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 12, 2008
First Posted Date  ICMJE September 16, 2008
Results First Submitted Date  ICMJE December 7, 2012
Results First Posted Date  ICMJE March 11, 2013
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE August 28, 2008
Actual Primary Completion Date June 30, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. ]
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)]
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
The primary objective of this study is to determine the efficacy (assessed by progression free survival [PFS]) of AZD2281 compared to placebo in this patient population [ Time Frame: Radiological tumour assessments will occur every 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • Overall Survival (OS) [ Time Frame: Follow up every 12 weeks post progression, assessed maximum up to 90 months. ]
    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.
  • Objective Response Rate (ORR) (According to RECIST) [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. ]
    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
  • Disease Control Rate [ Time Frame: Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week). ]
    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]
  • Duration of Response [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. ]
    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.
  • Percentage Change From Baseline in Tumour Size at Week 24 [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months. ]
    Percentage change from baseline to Week 24 in target tumour size.
  • Best Percentage Change in Cancer Antigen 125 (CA-125) Levels [ Time Frame: CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months. ]
    Best percentage change from baseline in CA-125 level
  • Best Objective Response [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months. ]
    Best overall response from radiologic assessments. [FAS]
  • RECIST and CA-125 Response Separately and Combined [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months. ]
    RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]
  • Time to Earlier of CA-125 or RECIST Progression [ Time Frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months. ]
    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]
  • Improvement Rate for FACT-O Symptom Index (FOSI) [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. ]
    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]
  • Improvement Rate for Trial Outcome Index (TOI) [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. ]
    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]
  • Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. ]
    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]
  • FACT-O Symptom Index (FOSI) Time to Worsening [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. ]
    The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]
  • Trial Outcome Index(TOI)Time to Worsening [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. ]
    The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]
  • Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening [ Time Frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months. ]
    The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
  • The secondary objectives of this study are to determine the efficacy of AZD2281 compared to placebo by assessment of overall survival (OS), best overall response, duration of response, Cancer antigen (CA)-125 response (Gynecologic CancerInterGroup [GCIG] [ Time Frame: CA-125 measurements will be performed every 28 daysradiological tumour assessments will be performed every 12 weeks for 1st 60 weeks and then every 24 weeks ]
  • Adverse events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, haematology and urinalysis. [ Time Frame: Safety assessments will generally be performed every 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • Drug: AZD2281
    Oral 400mg bid
    Other Name: olaparib
  • Drug: matching placebo
    matching placebo bid
Study Arms  ICMJE
  • Experimental: 1
    AZD2281
    Intervention: Drug: AZD2281
  • Placebo Comparator: 2
    matching placebo
    Intervention: Drug: matching placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 20, 2018)
265
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2008)
250
Estimated Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date June 30, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
  • Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
  • For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
  • Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.

Exclusion Criteria:

  • Previous treatment with PARP inhibitors including AZD2281
  • Patients with low grade ovarian carcinoma.
  • Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
  • Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Estonia,   France,   Germany,   Israel,   Netherlands,   Poland,   Romania,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries Austria,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00753545
Other Study ID Numbers  ICMJE D0810C00019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Supporting Materials: Study Protocol
Supporting Materials: 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 de-identified 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
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mika Sovak, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Prof Jonathan A Lederman University College, London
PRS Account AstraZeneca
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP