AZD2014 and Weekly Paclitaxel in Squamous NSCLC
Condition: Squamous Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Open-label AZD2014; paclitaxel
Intervention description: Dual TORC1/TORC2 inhibitor; Taxane
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of
      AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically proven squamous non-small cell lung cancer (NSCLC)
             where treatment with weekly paclitaxel is an appropriate treatment option.

          2. Relapsed or refractory disease after at least one line of prior therapy. Subjects must
             have previously received appropriate line(s) of standard of care (SOC) treatment.

          3. Measurable disease by RECIST v1.1 criteria

          4. Life expectancy of at least 12 weeks.

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

        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