Study Stopped
The study was terminated early by the sponsor.
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 Docetaxel and Placebo Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer Patients
1 other identifier
interventional
48
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2014
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
June 14, 2016
CompletedJune 14, 2016
April 1, 2016
1.2 years
March 7, 2014
March 22, 2016
May 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
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.
Up to 20 months
Secondary Outcomes (1)
Pharmacokinetic Profile of AZD 1775 in Combination With Docetaxel
Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity
Study Arms (2)
AZD 1775, antimitotic, pegfilgrastim
EXPERIMENTALAZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles
Placebo + antimitotic + pegfilgrastim
PLACEBO COMPARATORPlacebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles
Interventions
AZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
Placebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
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
Related Publications (1)
Johnson ML, Dakhil SR, Beck JT, Sadiq A, Menon S, Mugundu GM, Chmielecki J, Spigel DR. Two Phase II Trials of Adavosertib, a Wee1 Inhibitor with Docetaxel or Carboplatin plus Pemetrexed in Non-small-cell Lung Cancer. Target Oncol. 2025 Nov;20(6):967-978. doi: 10.1007/s11523-025-01177-x. Epub 2025 Nov 10.
PMID: 41212474DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The sponsor terminated the study early. The study was closed on May 12, 2015. Part B of the study was not done.
Results Point of Contact
- Title
- Charles H. Davis
- Organization
- SCRI Development Innovations
Study Officials
- STUDY CHAIR
David R Spigel, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2014
First Posted
March 14, 2014
Study Start
March 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 14, 2016
Results First Posted
June 14, 2016
Record last verified: 2016-04