Phase 1 study of CEP-9722 in Patients With Advanced Solid Tumours

• Research type

  Research Study

• Full title

  An Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP-1 and PARP-2 Inhibitor) as Single-Agent Therapy and as Combination Therapy With Temozolomide in Patients With Advanced Solid Tumors

• IRAS ID

  16168

• Contact name

  Elizabeth Ruth Plummer

• Contact email

  Ruth.Plummer@newcastle.ac.uk

• Sponsor organisation

  Cephalon France

• Eudract number

  2008-006858-18

• ISRCTN Number

  Not available

• Research summary

  The aim of this study is to evaluate CEP-9722 a new anti-cancer agent in combination with temozolomide in patients with advanced solid tumours. CEP-9722 is a selective inhibitor of specific enzymes (called PARPs) which are present in the body. These enzymes - PARPs - are important in changing how the body would normally repair DNA. The inhibition of PARP activity has the potential to inhibit the DNA repair in the tumour cells and then reduce the tumour activity. Temozolomide, has been approved in some kinds of primary brain tumours and has already been combined with PARP inhibitors (other than CEP-9722) with an acceptable safety profile and manageable adverse effects and with substantial improvement of efficacy.The purpose of this study is to look at how well the participant tolerates the study drug, what effect the body has on the study drug, and the activity of the drug. This is a phase 1 study; CEP-9722 has not been studied previously in humans.A total of approximately 25 to 55 patients will be enrolled in 2 centers in Europe (one in France and one in the UK). This study is a Ó?dose escalation study?. This means that the first few patients to take part are given a very small dose of the study drug. If all goes well the next few patients have a slightly higher dose. The dose is gradually increased with each group until the optimum dose is found. Both the doctor and the participant will be aware of what treatment and dose the patient will be on.Patients will continue to receive treatment as long as the study drug helps and they do not experience side effects that cannot be controlled or if the patients voluntarily decides to stop study drug treatment.This study is sponsored by Cephalon, Inc

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  09/H0904/22

• Date of REC Opinion

  29 Jun 2009

• REC opinion

  Further Information Favourable Opinion