NKTR-102 in Patients with Metastatic Colorectal Cancer

• Research type

  Research Study

• Full title

  A Multicenter, Open-Label, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of NKTR 102 (PEG-Irinotecan) Versus Irinotecan in Patients with Second-Line, Irinotecan-Naïve, KRAS-Mutant Metastatic Colorectal Cancer (mCRC). Protocol Number: 08-PIR-03

• IRAS ID

  12778

• Sponsor organisation

  Nektar Therapeutics

• Eudract number

  2008-004093-40

• Research summary

  HOW DOES TREATMENT WITH THE INVESTIGATIONAL PRODUCT NKTR-102 (PEG-IRINOTECAN) COMPARE WITH IRINOTECAN (CAMPTO©) IN PATIENTS WITH COLORECTAL CANCER WHO HAVE KRAS MUTATIONS? The aim of palliative chemotherapy is to both maintain quality of life and extend life. In patients with metastatic colorectal cancer whose tumour carries a defect in a specific growth pathway (known as Kras mutant) the treatment option of cetuximab and irinotecan is not appropriate, so single agent irinotecan is often used. Non-clinical data suggest that pegylated irinotecan (NKTR 102) has the potential to not only improve outcome (response rate and extended survival) but also cause less toxicity (more safe) compared with single agent irinotecan. In this study patients with metastatic colorectal cancer who have failed a first linfluropyrimidine containing regimen and who also have a defect or mutation in the Kras growth pathway will be randomised between NKTR 102 and single agent irinotecan to assess and compare the efficacy (response rate & survival) and safety (toxicity) of these two treatment arms. The study will be conducted in the United Kingdom by oncologists with a special interest in colorectal in NHS oncology centres used to looking after patients receiving chemotherapy in clinical trials. Within the study patients who agree to take part will be randomised (in a 1:1 fashion) before receiving treatment between NKTR 102 and irinotecan. Each treatment cycle lasts 21 days and patients will receive repeated cycles, with clinical assessment before every cycle and formal imaging assessment (with Ct or MRI scans) every 6 weeks until progression of disease, unacceptable side effects or a decision by the patient or their oncologist to stop the treatment. On completion of treatment patients will be followed in clinic every month to monitor any residual side effects, survival and any further treatment the patient may receive.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/48

• Date of REC Opinion

  22 Oct 2009

• REC opinion

  Further Information Favourable Opinion