BaP

• Research type

  Research Study

• Full title

  Single Arm Phase II trial assessing the safety, compliance with and activity of Bezafibrate and medroxyProgesterone acetate (BaP) as non-toxic therapy against myeloid and lymphoid cancers

• IRAS ID

  89213

• Contact name

  Mark Drayson

• Sponsor organisation

  University of Birmingham

• Eudract number

  2011-001955-35

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The aim of this clinical study is to evaluate how safe and effective a drug combination called ??BaP? is when treating patients with the following blood cancers; Acute Myeloid Leukaemia (AML), Myelodysplastic Syndromes (MDS RAEB2), Chronic Lymphocytic Leukaemia (CLL), and B-Cell Non-Hodgkin??s Lymphoma (BHNL). The study will recruit patients who are not suitable for other therapies because their disease has become resistant or they are too frail to tolerate the toxicity of conventional therapies. The drug combination of Bezafibrate and medroxyprogesterone has potential anti-cancer efficacy without toxicity. 60 patients (20 from each disease type) will receive BaP for 18 weeks at which point they will have a clinical disease assessment to assess response. The clinical assessment may include blood tests/film, a bone marrow biopsy or CT scan as applicable to the disease type. A small trial of 20 patients with AML showed no haematological toxicity from BaP and significant haematological and disease responses were observed. Laboratory studies suggest that giving BaP at a higher dose than this study may provide an even greater response. A trial in children with Burkitt??s Lymphoma has shown the dose to be given in this study to be well tolerated in 20 patients. However, as with all drugs, some side effects may occur and patients will be monitored closely to ensure these are managed. There is no guaranteed benefit to taking part in this research. The study will recruit for approximately 14 months from four hospitals across the West Midlands. It is anticipated recruitment will commence in December 2011. The study is funded by the Queen Elizabeth Hospital Birmingham Charity and will be managed by the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0426

• Date of REC Opinion

  15 Feb 2012

• REC opinion

  Further Information Favourable Opinion