A Phase II Clinical Trial in Patients with BRCA defective Tumours

• Research type

  Research Study

• Full title

  Phase II Clinical Trial of 6-Mercaptopurine(6MP)and low-dose Methotrexate In Patients With Known BRCA Defective Tumours.

• IRAS ID

  64399

• Contact name

  Shibani Nicum

• Sponsor organisation

  University of Oxford

• Eudract number

  2009-016846-16

• ISRCTN Number

  n/a

• Research summary

  IntroductionOvarian and breast cancer are major causes of death of women across the World. Sometimes inherited genetic changes (BRCA1 and 2 mutations) mean that these tumours respond differently to certain standard chemotherapies.This trial will assess these patients to see if their tumours will shrink in response to two tablet chemotherapies, 6MP and methotrexate.BackgroundHelleday et al have recently shown that 6 thioguanine (6TG) selectively kills BRCA2defective cells as effectively as thePARP inhibitor, AGO14699. Furthermore even after BRCA2defective cells have acquired resistance to a PARP inhibitor or cisplatin, they retain sensitivity to 6TG.Aims and ObjectivesTo determine the response rates and toxicity of 6MP with low dose methotrexate inpatients with breast or ovarian cancer who are known to have a BRCA mutation.MethodsMulticentre Phase II study recruiting 65 patients with relapsed advanced breast orovarian cancer who have received at least 1 prior line of chemotherapy and areknown to have a BRCA mutation.Patients will receive daily 6MP (75 mg/m2) and weekly low dose methotrexate(20mg/m2) until disease progression.How Results will be usedIf the efficacy criteria are met as defined in the protocol, then we anticipate moving straight on to a Phase III randomised controlled trial.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/79

• Date of REC Opinion

  25 Jan 2011

• REC opinion

  Further Information Favourable Opinion