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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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)]

Outcome 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

Safety Issue:

No

Principal Investigator

Jane Robertson, BSc, MBCHB, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

D0810C00019

NCT ID:

NCT00753545

Start Date:

August 2008

Completion Date:

November 2012

Related Keywords:

  • Ovarian Cancer
  • Serous,
  • Ovarian cancer,
  • PARP,
  • BRCA1,
  • BRCA2,
  • Poly(ADP ribose) polymerases,
  • Platinum sensitive,
  • Homologous Recombination Deficiency (HRD)
  • Ovarian Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Boca Raton, Florida  
Research Site Bloomington, Indiana  
Research Site Beverly, Massachusetts  
Research Site Albany, New York  
Research Site Pawtucket, Rhode Island