Safety study to Determine the MTD, PK and PD of SGI-1776 .

• Research type

  Research Study

• Full title

  Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of SGI-1776, a PIM Kinase Inhibitor, in Subjects with Hormone Refractory Prostate Cancer and Relapsed/Refractory non-Hodgkin’s Lymphoma.

• IRAS ID

  13488

• Sponsor organisation

  SuperGen Inc.

• Eudract number

  2008-007847-15

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The IMP, SGI-1776, will be available as capsules for oral use. It is believed to be active in prostate cancer in patients who have not responded to currently approved treatment. It is also believed to be active in non-Hodgkin’s lymphoma (NHL) in patients that either have a relapse or that do not respond to currently approved treatment, and are not eligible for treatment under the NCCN guideline. The main objective of the proposed study is to assess the safety and the maximum tolerated dose (MTD) of SGI-1776 in patients with either condition. Other objectives are to obtain pharmacokinetic data (details on how much drug is absorbed and eliminated, and how the drug is transformed in the body), data on how the drug works, and whether patients draw benefit. This is a non-comparative open study, where SGI-1776 will be administered for 14-day periods per 21-day treatment cycle. The number of treatment cycles will depend on the side-effects, the signs of toxicity, and on the how the patients respond to the treatment. Patients will be followed up for a period of 30 days following the last dose.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  09/H0801/3

• Date of REC Opinion

  26 Jan 2009

• REC opinion

  Favourable Opinion