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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Claire Paulding
-
Toparp-icrctsu@icr.ac.uk


Study Location:

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Be Part of Research - Trial Details - Phase II trial of olaparib in patients with advanced castration resistant prostate cancer

Phase II trial of olaparib in patients with advanced castration resistant prostate cancer

Not Recruiting

Open to: Male

Age: Adult

Medical Conditions

Topic: National Cancer Research Network
Subtopic: Prostate Cancer
Disease: Prostate


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

04 Jul 2012 31 Jan 2014

Publications

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26510020 results

Interventional

Intervention Type : Drug
Intervention Description : All patients will receive single agent olaparib (AZD2281) at a dose of 400 mg twice daily, continuously on a 28-day cycle. Olaparib will be administered until objective disease progression or unacceptable toxicity or patient withdrawal for whatever reason.




You can take part if:



You may not be able to take part if:


1. Surgery, or local prostatic intervention (excluding a prostatic biopsy) less than 28 days of Cycle 1 Day 1 2. Less than 28 days from any active anticancer therapy or investigational agents. For hormonal treatment and radiotherapy refer to the guidelines outlined in the inclusion criteria3. Prior treatment with a PARP inhibitor, platinum, cyclophosphamide or mitoxantrone chemotherapy4. Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements5. Any acute toxicities due to prior chemotherapy and / or radiotherapy that have not resolved to a National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.02 grade 1 with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy. 6. Malignancy within the previous 2 years with a > 30% probability of recurrence within 12 months with the exception of non-melanoma skin cancer, in-situ or superficial bladder cancer7. Patients with myelodysplastic syndrome/acute myeloid leukaemia8. Patients with known symptomatic brain metastasis are not suitable for enrolment. Patients with asymptomatic, stable, treated brain metastases are eligible for study entry9. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable and asymptomatic10. Patients who experience a seizures within 6 months of study treatment or who are currently being treated with cytochrome P450 enzyme inducing antiepileptic drugs for seizures (use of antiepileptic drugs to control pain is allowed in patients not suffering from seizures unless drug is excluded due to CYP3A4 induction phenytoin, carbamazepine, phenobarbital11. Patients receiving any of the following classes of inhibitors of CYP3A4; -Azole antifungals -Macrolide antibiotics -Protease inhibitors 12. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication13. Initiating bisphosphonate therapy or adjusting bisphosphonate dose/regimen within 30 days prior to Cycle 1 Day 1. Patients on a stable bisphosphonate regimen are eligible and may continue. 14. Presence of a condition or situation, which, in the investigatorÂ’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patientÂ’s participation in the study15. The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • ICR Clinical Trials & Statistics Unit (ICR-CTSU)
    Sutton
    SM2 5NG

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Ms Claire Paulding
-
Toparp-icrctsu@icr.ac.uk



The study is sponsored by The Institute for Cancer Research (UK); Royal Marsden Hospital NHS Foundation Trust (UK); Institute of Cancer Research and funded by AstraZeneca; Cancer Research UK (UK).




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Read full details for Trial ID: ISRCTN15124653
Last updated 31 March 2016

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