A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents

You likely can't join if

• 1 Patients with MDS/AML or with features suggestive of MDS/AML. 2 Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study drug. 3 Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia, and the laboratory values defined in the inclusion criterion. Patients with a toxicity not reasonably expected to be exacerbated by study treatment (eg, hearing loss, gastrostomy tube) may be included after consultation with the Study Physician. 4 Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography scan, ongoing or activeinfection, symptomatic congestive heart failure, cardiac arrhythmia, interstitial lung disease, or any psychiatric illness or social situations that would limit compliance with study requirements, substantially increase the risk of incurring AEs from IP, or compromise the ability of the patient to give written informed assent. 5 History of other primary malignancy unless curatively treated with no evidence of disease for ≥5 years. Non-invasive malignancies such as adequately treated non-melanoma skin cancer or in situ carcinomas that have been adequately treated may be permitted after detailed discussion with the Study Physician. 6 Patients with primary or metastatic CNS disease meeting the following criteria: (a) Symptomatic uncontrolled brain metastases at baseline. A scan to confirm the absence of brain metastases is not required. (b) Patients with brain metastases or primary brain tumours who require corticosteroids for management of symptoms or progression. (c) Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. 7 History of active primary immunodeficiency or immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV). 8 Patients with known active hepatitis (ie, Hepatitis B or C). (a) Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. (b) Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid. 9 Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the Investigator (eg, unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval (QTc) prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. 10 Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study treatment or interpretation of patient safety or study results.