- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087176
A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
May 6, 2016 updated by: AstraZeneca
A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 Plus Docetaxel and Placebo Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer Patients
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
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
This multicentre trial consists of an open-labelled single cohort lead-in (Part A) followed by a phase II double-blind, randomised, placebo-controlled comparison of AZD1775 (or placebo) and an antimitotic agent.
Review by a central laboratory of fresh tumour or archival tumour samples will be required prior to study entry to assess TP53 mutation status.
However, subjects will be allowed to enter the single cohort (Part A) regardless of TP53 mutation status (wild-type or mutant).
In addition, patients in the single cohort Part A treatment group will be asked to consent to limited sample collections for assessment of pharmacokinetic parameters.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Research Site
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Arizona
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Scottsdale, Arizona, United States
- Research Site
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Arkansas
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Fayetteville, Arkansas, United States
- Research Site
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Colorado
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Englewood, Colorado, United States
- Research Site
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Florida
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Orlando, Florida, United States
- Research Site
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Kansas
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Wichita, Kansas, United States
- Research Site
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Kentucky
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Louisville, Kentucky, United States
- Research Site
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North Carolina
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Durham, North Carolina, United States
- Research Site
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Ohio
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Cincinnati, Ohio, United States
- Research Site
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- Research Site
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Tennessee
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Nashville, Tennessee, United States
- Research Site
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Wisconsin
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Milwaukee, Wisconsin, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AZD 1775, antimitotic, pegfilgrastim
AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles
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AZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
Other Names:
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.
Other Names:
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 Names:
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Placebo Comparator: Placebo + antimitotic + pegfilgrastim
Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles
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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.
Other Names:
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 Names:
Placebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Objective Response Rate
Time Frame: Up to 20 months
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Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g.
CT or MRI).
The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures.
The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR).
Complete Response is defined as disappearance of all target lesions since baseline.
Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm.
Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.
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Up to 20 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pharmacokinetic Profile of AZD 1775 in Combination With Docetaxel
Time Frame: Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity
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Venous blood samples taken for determination of AZD1775, metabolites of 1775 on Cycle 1, Day 1 pre-dose and 2 hours post dose, Cycle 2 Day 1 pre-dose and 2 hours post dose, and Cycle 4 pre-dose and 2 hours post dose.
However, the study was terminated early by the sponsor; therefore, pharmacokinetic data were not collected.
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Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: David R Spigel, MD, SCRI Development Innovations, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
March 7, 2014
First Submitted That Met QC Criteria
March 13, 2014
First Posted (Estimate)
March 14, 2014
Study Record Updates
Last Update Posted (Estimate)
June 14, 2016
Last Update Submitted That Met QC Criteria
May 6, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Mitosis Modulators
- Adavosertib
- Antimitotic Agents
Other Study ID Numbers
- D6011C00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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