A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
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
Checked against the public recordLast updated Jun 14, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- AstraZeneca
- Interventions being studied
- Drug: AZD1775; Drug: AZD1775 Placebo; Drug: Antimitotic Agent; Drug: pegfiligrastim
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteBirmingham, Alabama
- Research SiteScottsdale, Arizona
- Research SiteFayetteville, Arkansas
- Research SiteEnglewood, Colorado
- Research SiteOrlando, Florida
- Research SiteWichita, Kansas
- Research SiteLouisville, Kentucky
- Research SiteDurham, North Carolina
- Research SiteCincinnati, Ohio
- Research SitePittsburgh, Pennsylvania
- Research SiteNashville, Tennessee
- Research SiteMilwaukee, Wisconsin
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 14, 2016. Always confirm current availability with the study team.