A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell Lung Cancer Patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Adavosertib; Antimitotic Agents; Docetaxel

Criteria

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures

• Histologic or cytologic diagnosis of advanced NSCLC, excluding large cell neuroendocrine, and mixed NSCLC/small-cell histologies

• Failure of one prior platinum-based doublet treatment for advanced NSCLC (either due to progressive disease or toxicity)

• Measurable disease as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 testing

• Male or female ≥18 years-of-age

• Subjects may have received radiation for palliation prior to starting study treatment if they have recovered from the side effects of such therapy

• Absolute neutrophil count (ANC) ≥1500/μL

• Haemoglobin (Hgb) ≥9 g/dL

• Platelets ≥100,000/uL

• Adequate liver function defined as:

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal limits (WNL) or ≤2.5 x upper limit of normal (ULN), if liver metastases are present

• Serum bilirubin WNL

• Adequate renal function

• Ability to swallow oral medication

• Fertile male subjects willing to use at least one medically acceptable form of birth control for the duration of the study and for 2 weeks after treatment stops

• Female subjects who are not of childbearing potential and fertile female subjects of childbearing potential who agree to use adequate contraceptive measures

• Predicted life expectancy ≥12 weeks

• Willingness and ability to comply with study and follow-up procedures

• Ability to understand the investigational nature of this study and give written informed consent

• Most recent chemotherapy ≤21 days or have not recovered from the side effects > Grade 1.

• Use of a study drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775

• Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting AZD1775 or has not recovered from side effects of such therapy

• Major surgical procedures ≤28 days of beginning AZD1775, or minor surgical procedures ≤7 days

• Known central nervous system (CNS) disease

• Any known hypersensitivity or contraindication to the components of study treatment (AZD1775 and docetaxel)

• Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association [NYHA] ≥ Class 2

• Pregnant or lactating

• Concurrent administration of medications or foods that are strong inhibitors of

• Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the subject to receive protocol treatment

• Presence of other active cancers, or history of treatment for invasive cancer ≤3 years

• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol