A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
NCT ID: NCT02087176
Last Updated: 2016-06-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
48 participants
INTERVENTIONAL
2014-03-31
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer
NCT02087241
Dose-Dense Induction/Neoadjuvant Chemotherapy in Locally Advanced Non-Small Cell Lung Cancer
NCT02157116
Double Blind Placebo Controlled Controlled Study of Adjuvant MEDI4736 In Completely Resected NSCLC
NCT02273375
AZD1775 Plus Carboplatin-Paclitaxel in Squamous Cell Lung Cancer
NCT02513563
A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer
NCT04611776
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZD 1775, antimitotic, pegfilgrastim
AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles
AZD1775
AZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
Antimitotic Agent
The antimitotic is a drug that stops cells from dividing. This leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by this drug.
pegfiligrastim
Pegfilgrastim is a man-made version of a protein called granulocyte-colony stimulating factor (G-CSF). This protein is made by cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells.Pegfilgrastim is made by attaching filgrastim to a molecule called polyethylene glycol (PEG). This addition helps it stay in the body longer than filgrastim, which means it can be given less often.
Placebo + antimitotic + pegfilgrastim
Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles
AZD1775 Placebo
Placebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
Antimitotic Agent
The antimitotic is a drug that stops cells from dividing. This leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by this drug.
pegfiligrastim
Pegfilgrastim is a man-made version of a protein called granulocyte-colony stimulating factor (G-CSF). This protein is made by cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells.Pegfilgrastim is made by attaching filgrastim to a molecule called polyethylene glycol (PEG). This addition helps it stay in the body longer than filgrastim, which means it can be given less often.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD1775
AZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
AZD1775 Placebo
Placebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
Antimitotic Agent
The antimitotic is a drug that stops cells from dividing. This leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by this drug.
pegfiligrastim
Pegfilgrastim is a man-made version of a protein called granulocyte-colony stimulating factor (G-CSF). This protein is made by cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells.Pegfilgrastim is made by attaching filgrastim to a molecule called polyethylene glycol (PEG). This addition helps it stay in the body longer than filgrastim, which means it can be given less often.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David R Spigel, MD
Role: STUDY_CHAIR
SCRI Development Innovations, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Fayetteville, Arkansas, United States
Research Site
Englewood, Colorado, United States
Research Site
Orlando, Florida, United States
Research Site
Wichita, Kansas, United States
Research Site
Louisville, Kentucky, United States
Research Site
Durham, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D6011C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.