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TerminatedPhase 2NCT02087176
Official study title

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

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAZD1775 and AZD1775 Placebo

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 14, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
Study topics
After prior treatment→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

04
Study sites

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.

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