AZD2014 and Weekly Paclitaxel in Squamous NSCLC

Exclusion Criteria

• •1. Radiotherapy (except for palliative reasons), chemotherapy, endocrine therapy, or immunotherapy during the previous 3 weeks (4 weeks for investigational medicinal products and 6 weeks for nitrosoureas and Mitomycin-C) before treatment.
• •2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or Grade 1 toxicities which, in the opinion of the Investigator, should not exclude the patient.
• •3. Known leptomeningeal involvement, brain metastases or spinal cord compression.
• •4. History of hypersensitivity (\> Grade 2) to active or inactive excipients of AZD2014, drugs containing Cremophor, taxanes or structurally/chemically similar drugs
• •5. Current refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated product or previous significant bowel resection that would preclude adequate absorption of AZD2014
• •6. Patients with Diabetes Type I or uncontrolled Type II (HbA1c \> 59 mmol/mol assessed locally) as judged by the Investigator
• •7. Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study and from which the patient has not yet recovered
• •8. Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening (with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening), defined as:
• •* Absolute neutrophil count 1500 cells/mm3 (1.5 x 109/L)
• •* Platelet count 100.000 cells/mm3 (100 x 109/L)
• •* Haemoglobin 9.0 g/dL
• •9. Adequate hepatic and renal function defined as:
• •* Serum aspartate transaminase (AST) or alanine transaminase (ALT) 2.5 x upper limit of normal (ULN) if no demonstrable liver metastases or 5 x ULN in the presence of liver metastases
• •* Alkaline phosphatase (ALP) \< 5 x ULN
• •* Serum bilirubin 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
• •* Estimated Creatinine Clearance 50 ml/min (Cockcroft-Gault) or serum creatinine 1.5 x ULN