A Clinical Trial in Patients With BRCA Defective Tumours (6MP)
|ClinicalTrials.gov Identifier: NCT01432145|
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : May 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ovarian Cancer||Drug: 6-Mercaptopurine Drug: Methotrexate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Trial Of 6-Mercaptopurine (6MP) and Low-Dose Methotrexate In Patients With Known BRCA Defective Tumours|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||May 2015|
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.
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.
- 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. ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432145
|Oxford, United Kingdom, OX3 7LJ|
|Principal Investigator:||Shibani Nicum||University of Oxford|