A Clinical Trial in Patients With BRCA Defective Tumours (6MP)
This study will evaluate the efficacy and safety of 6MP in combination with methotrexate in patients with breast or ovarian cancer who are known to have a BRCA mutation. 6MP is used instead of 6TG as it is converted to the same cytotoxic moiety as 6TG, ie. thioguanine nucleotides, but with reduced toxic effects. Low dose methotrexate is used in combination with 6MP as it promotes the formation of thioguanine nucleotides.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Trial Of 6-Mercaptopurine (6MP) and Low-Dose Methotrexate In Patients With Known BRCA Defective Tumours|
- To determine the objective response rate to 6MP/MTX in this patient population. [ Time Frame: Up to 24 weeks after the 30th (65th) patient has been recruited. ] [ Designated as safety issue: No ]
1st stage: If less than 3/30 evaluable patients respond at 8 weeks the trial will be stopped for futility. If 3 or more out of 30 evaluable patients respond then a further 35 patients will be recruited (2nd stage).
The proportion of patients responding to treatment will be presented, together with 95% confidence intervals, for Stage 1 and overall, if applicable. This will be repeated separately for patients previously treated with/without PARP inhibitors.
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
The dose of 6MP will be 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. Tablets should be taken at roughly the same time each day. One cycle is 28 days. Treatment is given continuously (see table below) until disease progression.Drug: Methotrexate
Methotrexate (20 mg/m2) will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously (see table below) until disease progression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432145
|Oxford, United Kingdom, OX3 7LJ|
|Principal Investigator:||Shibani Nicum||University of Oxford|