A signal seeking window trial of AZD8931 in patients with resectable non-small cell lung cancer - Window Trial of AZD8931 in resectable non-small cell lung cancer

Phase 1

• Conditions: resectable non-small cell lung cancer; MedDRA version: 14.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-001518-33-GB
• Lead Sponsor: niversity Hospital of South Manchester NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-30
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

•Age 18 years or older.
•Histologically confirmed NSCLC
•Operable disease as determined by local staging investigations, including CT scan of thorax and abdomen, FDG-PET scan and mediastinoscopy where indicated as a standard of care.
•Availability of surplus diagnostic biopsy tissue
•WHO performance status 0 or 1
•Haematology (These measurements must be performed within two weeks prior to the patient going on study):
Haemoglobin (Hb) > 9 g/dl
Neutrophils > 1.5 x 10 9/L
Platelets > 100 x 109/L
Partial thromboplastin time (PTT) and Prothrombin time (PT) < 1.5 x ULN
•Hepatic function
Serum bilirubin < 1.5 x upper limit of normal (ULN)
Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 2.5 X ULN
•Adequate renal function (calculated clearance > 50 ml/min as per calculated Cockcroft formula
•Ability to give written informed consent according to ICH/GCP, and national/local regulations.
•Ability to co-operate with study treatment and follow up

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Pregnancy. Only women of NONE child bearing potential may enter the study. Women must be permanently or surgically sterilized or postmenopausal* (see protocol for definitions).
•Previous systemic treatment, radiotherapy or surgery for current lung cancer
•Serious pre-existing medical co-morbidities, e.g. uncontrolled diabetes mellitus, uncontrolled respiratory or cardiac disease or ongoing or active infection (including HIV)
•Psychiatric illness and/or social situation that would preclude study compliance
•Prior (within the past 2 years) or concurrent malignancy (except adequately treated non-melanomatous skin cancer and resected cervical carcinoma in situ)
•Baseline resting ECG with measurable QTc interval >480msec.
•Echocardiogram confirming inadequate left ventricular function, LV ejection fraction<45%.
•Known uncontrolled or symptomatic angina, arrhythmias or congestive heart failure, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg), significant valvular disease or history of high risk dysrrhythmia (such as ventricular fibrillation or ventricular tachycardia [includes ventricular triplets])
•Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
•Significantly impaired visual acuity
•Medication that induces or inhibits CYP3A4 or reduces gastric acid production unless medically indicated

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified