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|
|Primary Completion Date :||December 2014|
|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.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.
- 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|