This is a randomised, double-blind placebo controlled phase 2 trial. Patient will be randomly
assigned 1:1 between 2 treatment arms. They will receive either docetaxel 75mg/m2 IV and
placebo given bd, or AZD6244 75mg bd daily with docetaxel 75mg/m2 IV. Docetaxel will be
administered every 3 weeks for a maximum 6 cycles, but AZD6244/placebo may be continued
beyond this, until disease progression. The objective is to assess whether the combination of
AZD6244 with docetaxel is worthy of evaluation in a definitive randomised study, with the
null hypothesis being that the combination has activity similar to that of docetaxel alone in
this population. After consent has been obtained mutational analysis of tumour BRAF will be
performed on archival tumour tissue, where this information is not already known, to assess
eligibility for the study. If there is no archival tissue a fresh biopsy will be requested
from the patient. A blood sample will also be taken for future genetic analysis. Once taking
part in the trial patients will need to attend their oncology unit regularly for monitoring
and the delivery of treatment. Patients will undergo complete physical examination at
screening, on C1D1, C1D8, C1D15, C2D1, C2D8 and day 1 of every subsequent cycle. Blood for
haematology, biochemistry and clotting will be taken at each of these visits. A 12 lead ECG
will be performed at screening . Disease assessment will be by CT scanning using modified
RECIST criteria after 9 and 18 weeks, then every 3 months until disease progression.