Assessment of Efficacy of AZD2281 in Platinum Sensitive Serous Ovarian Cancer

Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000159257

Enrollment

250

Registered

2009-03-26

Start date

2008-08-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to determine the efficacy of the study drug AZD2281 compared to placebo by looking at progression free survival of the patients. Progression will be determined by tumour assessments and evaluations and patients will have regular imaging scans. The study hypotheses that AZD2281 given after an objective stable maintained response on completion of platinum containing chemotherapy improves progression free survival compared to placebo in platinum sensitive serous advanced ovarian cancer patients who have previously received two or platinum containing regimens.

Interventions

AZD2281 or Olaparib is a potent inhibitor of polyadenosine 5’-diphosphoribose polymerase (PARP) that is being developed as an oral treatment for patients with BRCA (Breast Cancer Gene Type) related cancer. The molecular targeting of olaparib to specific subsets of tumours may provide an opportunity for less toxic cancer monotherapy and adjuvant therapy, compared with currently available regimen. In this study, AZD2281 will be given orally 400mg twice daily. Participants will be receiving AZD2281 till their tumour assessment (via imaging scans) show disease progression according to the protocol. They can chose to stop participating in the study and hence stop receiving the drug. Their doctors or the sponsor may also stop them from receiving the study drug if it was discovered that patient is at risk, non-compliant, or for other reasons.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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 previous 2 chemo regimens. 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 polyadenosine 5’-diphosphoribose polymerase (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).

Outcome results