Safety and Pharmacokinetics Study of Panobinostat in Renal Failure

• Research type

  Research Study

• Full title

  A phase I, open-label, multi-center study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and varying degrees of renal function

• IRAS ID

  104360

• Contact name

  Syed Hussain

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-012263-34

• Research summary

  The study is open label, non-comparative study in adult patients with advanced solid tumours with varying levels of renal function and is divided into two phases. The first phase, the core phase, is a 7 day pharmacokinetic and safety study of a single 30 mg oral dose of panobinostat. The second phase is the extension phase, during which 28-day cycles of panobinostat (30 mg dose on day 1, 3 & 5) will be given until the patient completes the study. Adult patients with advanced solid tumours for which no standard therapy exists, who have given their written informed consent, will be enrolled into the trial. Patients will undergo the screening assessments, along with a 24 hour creatinine clearance. They will also undergo a radiological assessment (computerised tomography (CT) scan, magnetic resonance imaging (MRI) scan, x-rays or bone scan, as is appropriate for their disease, during the the four weeks prior to the start of panobinostat treatment. Patients will be classified into normal (10 patients), mildly-impaired (10), moderately-impaired (10 ) or severely-impaired (up to 6) renal function. The pharmacokinetics and safety of panobinostat will be studied over 7 days in the core phase. In the extension phase, 30 mg panobinostat will be administered orally on days 1, 3 and 5 in a 28-day cycle. Patients with severe renal impairment may receive a lower dose. Panobinostat treatment then continues until disease progression, patient start a new cancer treatment, unacceptable toxicity, withdrawal of consent by the patient or if the patient is withdrawn by the investigator. Patients will visit the clinic on days 1 and 15 of each cycle for safety assessments. Their tumour will be monitored, as is appropriate for that tumour and in accordance with usual clinical practice. A complete set of safety assessments will be performed on completion of treatment.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0460

• Date of REC Opinion

  30 Jul 2012

• REC opinion

  Further Information Favourable Opinion