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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- AstraZeneca
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Objective Response Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AZD 1775, antimitotic, pegfilgrastim
AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles
Intervention: AZD1775 (Drug)
AZD 1775, antimitotic, pegfilgrastim
AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles
Intervention: Antimitotic Agent (Drug)
AZD 1775, antimitotic, pegfilgrastim
AZD 1775, antimitotic agent + pegfilgrastim 21 day Cycle, maximum of 4 cycles
Intervention: pegfiligrastim (Drug)
Placebo + antimitotic + pegfilgrastim
Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles
Intervention: AZD1775 Placebo (Drug)
Placebo + antimitotic + pegfilgrastim
Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles
Intervention: Antimitotic Agent (Drug)
Placebo + antimitotic + pegfilgrastim
Placebo + antimitotic+pegfilgrastim 21 day cycle, maximum of 4 cycles
Intervention: pegfiligrastim (Drug)
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: 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 Outcomes
- 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)