RecruitingPhase 2ACTRN12609000159257

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


Sponsor

Astra Zeneca

Enrollment

250 participants

Start Date

Aug 30, 2008

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for women with a type of ovarian cancer called platinum-sensitive serous ovarian cancer. It is testing a drug called olaparib (AZD2281), which works in a different way from standard chemotherapy by blocking a protein that cancer cells need to repair their DNA. The goal is to find out whether taking olaparib after responding to platinum-based chemotherapy can delay the cancer from growing back (called progression-free survival). You may be eligible if: - You are a woman (18+) with a confirmed diagnosis of serous ovarian cancer (including recurrent disease) - You have completed at least 2 previous courses of platinum-based chemotherapy - Your cancer responded to both previous chemotherapy courses (partial or complete response) - Your cancer is still responding at the end of your most recent chemotherapy - You started the study within 8 weeks of completing your last chemotherapy dose You may NOT be eligible if: - You have previously received a PARP inhibitor (including olaparib) - You have low-grade ovarian cancer - You had fluid drained from your abdomen during the last 2 cycles of chemotherapy - You received chemotherapy or radiotherapy (for non-palliative reasons) within 2 weeks before joining Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 c

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.


Locations(9)

Szczecin, Lublin, Poznan,, Poland

Iasi, Suceava, Baia Mare, Cluj-Napoca,, Romania

Ukraine

United States of America

Czech Republic

United Kingdom

Brussel, Leuven, Belgium

Wiesbaden, Kiel, Marburg, Ulm, G?ttingen, Essen, Germany

Tel-Aviv, Jerusalem, Tel-Hashomer, Nahariya, Zerifin, Israel

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ACTRN12609000159257