AZD2014 and Weekly Paclitaxel in Squamous NSCLC

Stopped early · Phase 2

Conditions studied: Squamous Non Small Cell Lung Cancer

In brief

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)

Key facts

Study ID

NCT02403895

Run by

AstraZeneca

People needed

11

Starts

2015-04-15

Expected to finish

2016-12-29

Last updated by the study team

2018-07-03

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically proven squamous non-small cell lung cancer (NSCLC) where treatment with weekly paclitaxel is an appropriate treatment option.
• 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.
• Measurable disease by RECIST v1.1 criteria
• Life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if…

• 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.
• 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.
• Known leptomeningeal involvement, brain metastases or spinal cord compression.
• History of hypersensitivity (> Grade 2) to active or inactive excipients of AZD2014, drugs containing Cremophor, taxanes or structurally/chemically similar drugs
• 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
• Patients with Diabetes Type I or uncontrolled Type II (HbA1c > 59 mmol/mol assessed locally) as judged by the Investigator
• 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
• 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
• 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

Where it is running

• Research Site — Boston, Massachusetts, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Hershey, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Gauting, Germany
• Research Site — Barcelona, Spain
• Research Site — Girona, Spain

Full record on ClinicalTrials.gov

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