ADI-PEG 20 small cell: LUD2009-007

• Research type

  Research Study

• Full title

  Phase II Study of ADI-PEG 20 in Patients with Relapsed Sensitive or Refractory Small Cell Lung Cancer

• IRAS ID

  38711

• Contact name

  Peter Szlosarek

• Sponsor organisation

  Ludwig Institute For Cancer Research

• Eudract number

  2009-017885-22

• Clinicaltrials.gov Identifier

  NCT01266018

• Research summary

  This is an open-label, phase II study to determine whether treatment with ADI-PEG 20 will shrink small cell lung cancer. ADI-PEG 20 is an experimental drug that breaks down arginine, which is an amino acid that is important for tumor growth. Normal human cells can make arginine; however certain cancers, such as small cell lung cancer, do not have the enzyme, argininosuccinate synthetase (ASS) and cannot make the arginine on their own. These cancer cells get the arginine from the blood. Using ADI-PEG 20 will starve the tumour cells of arginine, thereby preventing its growth. ADI-PEG 20 will be administered intramuscularly (IM) at a fixed dose of 320 I.U. mg/m2 OR 36.8 mg/m2 once weekly for a 4-week cycle.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/0524

• Date of REC Opinion

  17 Apr 2012

• REC opinion

  Favourable Opinion