A Placebo Controlled Study Comparing AZD1775+ Docetaxel Versus Placebo+Docetaxel to Treat Lung Cancer
- Conditions
- Previously Treated Non Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02087176
- Lead Sponsor
- AstraZeneca
- 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
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD 1775, antimitotic, pegfilgrastim Antimitotic Agent AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles Placebo + antimitotic + pegfilgrastim Antimitotic Agent Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles Placebo + antimitotic + pegfilgrastim AZD1775 Placebo Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles AZD 1775, antimitotic, pegfilgrastim pegfiligrastim AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles Placebo + antimitotic + pegfilgrastim pegfiligrastim Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles AZD 1775, antimitotic, pegfilgrastim AZD1775 AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles
- Primary Outcome Measures
Name Time Method Objective Response Rate Up to 20 months 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (1)
Research Site
🇺🇸Milwaukee, Wisconsin, United States