VanSel-1: A Phase I trial of Vandetanib and Selumetinib.

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase I dose escalation trial of oral VEGFR and EGFR inhibitor, Vandetanib in combination with the oral MEK inhibitor, Selumetinib (VanSel-1) in solid tumours (dose escalation) and NSCLC (expansion cohort).

• IRAS ID

  87422

• Contact name

  Denis Talbot

• Sponsor organisation

  Cancer Research

• Eudract number

  2011-000627-33

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this Phase I study is to establish a safety and toxicity profile of combining two study drugs; vandetanib, a VEGFR (Vascular Endothelial Growth Factor Receptor) and EGFR (Epidermal Growth Factor Receptor) inhibitor, with selumetinib a MEK (Mitogen Activated Kinase) inhibitor. This is the first time the drugs have been used together. These types of drugs have shown an effect in non small cell lung cancer (NSCLC) therefore the aim is to see if combining these drugs has an increased anti-tumour effect for this group of patients for which treatment options are limited. The study is in two parts; the dose escalation phase and the expansion cohort.In the dose escalation phase, 9-18 patients will receive vandetanib and increasing doses of selumetinib to establish a safe dose to recommend for the next stage of the study. Patients with any solid tumour will be eligible.In the expansion cohort, approximately 30 patients will receive the dose recommended in the previous phase. Only patients with NSCLC will be eligible for this part of the study. The expansion cohort will look at further evaluating the safety of the drug combination and the anti-tumour activity. Patients in this cohort will be requested to also consent to have additional imaging assessments and optional tumour biopsies.Study treatment is administered orally; vandetanib tablets once daily and selumetinib capsules twice daily. Cycle 1 is 42 days long. Subsequent cycles are 28 days in length. Patients will receive a total of 6 cycles of the combination treatment. If the patient has not progressed after six cycles, they may be treated for further cycles following approval from the sponsor.The study plans to open at approximately 4 centres across the UK and standard safety assessments will be performed throughout the trial.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0409

• Date of REC Opinion

  21 Oct 2011

• REC opinion

  Further Information Favourable Opinion