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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00753545
First Posted: September 16, 2008
Last Update Posted: November 17, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Ovarian Cancer Drug: AZD2281 Drug: matching placebo Phase 2

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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)]


Secondary Outcome Measures:
  • 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]


Enrollment: 326
Actual Study Start Date: August 28, 2008
Estimated Study Completion Date: December 29, 2017
Primary Completion Date: June 30, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD2281
Drug: AZD2281
Oral 400mg bid
Other Name: olaparib
Placebo Comparator: 2
matching placebo
Drug: matching placebo
matching placebo bid

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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): NCT00753545


  Hide Study Locations
Locations
United States, California
Research Site
Berkeley, California, United States, 94704
Research Site
Los Angeles, California, United States, 90048
Research Site
San Francisco, California, United States, 94115
United States, Florida
Research Site
Sunrise, Florida, United States, 33027
Research Site
West Palm Beach, Florida, United States, 33401
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
Research Site
Boston, Massachusetts, United States, 02115
Research Site
Boston, Massachusetts, United States, 02215
United States, New York
Research Site
New York, New York, United States, 10016
United States, Rhode Island
Research Site
Providence, Rhode Island, United States, 02905
Australia
Research Site
East Bentleigh, Australia, 3165
Research Site
Heidelberg, Australia, 3084
Research Site
Melbourne, Australia, 3000
Research Site
Nambour, Australia, 4560
Research Site
North Terrace, Australia, 5000
Research Site
Randwick, Australia, 2031
Research Site
Toorak Gardens, Australia, 5065
Belgium
Research Site
Brussels (Jette), Belgium, 1090
Research Site
Leuven, Belgium, 3000
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Research Site
Sherbrooke, Quebec, Canada, J1H 5N4
Czechia
Research Site
Brno, Czechia, 625 00
Estonia
Research Site
Tallinn, Estonia, 11619
France
Research Site
Bordeaux Cedex, France, 33076
Research Site
Lyon Cedex 08, France, 69373
Research Site
Nantes Cedex 02, France, 44202
Research Site
Paris, France, 75004
Research Site
Paris, France, 75020
Germany
Research Site
Düsseldorf, Germany, 40217
Research Site
Essen, Germany, 45122
Research Site
Göttingen, Germany, 37075
Research Site
Hannover, Germany, 30177
Research Site
Kiel, Germany, 24105
Research Site
Marburg, Germany, 35043
Research Site
München, Germany, 81675
Research Site
Ulm, Germany, 89081
Research Site
Wiesbaden, Germany, 65199
Israel
Research Site
Haifa, Israel, 31096
Research Site
Holon, Israel, 58100
Research Site
Jerusalem, Israel, 91031
Research Site
Jerusalem, Israel, 91120
Research Site
Nahariya, Israel, 22100
Research Site
Tel-Aviv, Israel, 64239
Research Site
Tel-Hashomer, Israel, 52621
Poland
Research Site
Białystok, Poland, 15-027
Research Site
Grzepnica, Poland, 72-003
Research Site
Lublin, Poland, 20 - 081
Research Site
Poznan, Poland, 60-569
Research Site
Poznan, Poland, 61-866
Research Site
Poznań, Poland
Research Site
Szczecin, Poland, 70-111
Romania
Research Site
Baia Mare, Romania, 430222
Research Site
Cluj-Napoca, Romania, 400015
Research Site
Iasi, Romania, 700106
Research Site
Suceava, Romania, 720237
Russian Federation
Research Site
Barnaul, Russian Federation, 656049
Research Site
Ekaterinburg, Russian Federation, 620036
Research Site
Obninsk, Russian Federation, 249036
Research Site
Orenburg, Russian Federation, 460021
Research Site
Perm, Russian Federation, 614066
Research Site
St. Petersburg, Russian Federation, 197002
Spain
Research Site
Barcelona, Spain, 08035
Research Site
Córdoba, Spain, 14004
Research Site
Madrid, Spain, 28007
Research Site
Madrid, Spain, 28041
Research Site
Valencia, Spain, 46010
Ukraine
Research Site
Donetsk, Ukraine, 83092
Research Site
Kharkiv, Ukraine, 61024
Research Site
Kyiv, Ukraine, 03022
Research Site
Kyiv, Ukraine, 03115
Research Site
Odesa, Ukraine, 65055
Research Site
Ternopil, Ukraine, 46023
Research Site
Uzhgorod, Ukraine, 88014
United Kingdom
Research Site
Bebington, United Kingdom, CH63 4JY
Research Site
Dundee, United Kingdom, DD1 9SY
Research Site
Edinburgh, United Kingdom, EH4 2XR
Research Site
London, United Kingdom, NW1 2PG
Research Site
London, United Kingdom, SW17 0QT
Research Site
Manchester, United Kingdom, M20 4BX
Research Site
Northwood, United Kingdom, HA6 2RN
Research Site
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mika Sovak, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Prof Jonathan A Lederman University College, London
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00753545     History of Changes
Other Study ID Numbers: D0810C00019
First Submitted: September 12, 2008
First Posted: September 16, 2008
Results First Submitted: December 7, 2012
Results First Posted: September 29, 2011
Last Update Posted: November 17, 2017
Last Verified: October 2017

Keywords provided by AstraZeneca:
Serous,
Ovarian cancer,
PARP,
BRCA1,
BRCA2,
Poly(ADP ribose) polymerases,
Platinum sensitive,
Homologous Recombination Deficiency (HRD)

Additional relevant MeSH terms:
Ovarian Neoplasms
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immune System Diseases
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents