Previously Treated Non Small Cell Lung Cancer Clinical Trial
Official title:
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
| Verified date | June 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | Englewood | Colorado |
| United States | Research Site | Fayetteville | Arkansas |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Scottsdale | Arizona |
| United States | Research Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate | The objective response rate is defined as the number of the subjects with a confirmed best overall response of CR or PR divided by the number of subjects in the Full Analysis Set (FAS) for whom measureable disease is present at baseline. | Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity | No |
| Primary | Disease Control Rate | The disease control rate is defined as the percentage of full analysis set subjects with a best overall response of CR, PR or SD). | Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity | No |
| Primary | Progression Free Survival (PFS) | PFS is defined as the time from randomisation, or date of study drug administration in the open label phase, until the date of objective disease progression or death by any cause in the absence of progression | Up to projected 20 months, subjects will be restaged after every 2 cycles in Part B (every 6 weeks) continue until disease progression or unacceptable toxicity | No |
| Secondary | Safety and Tolerability of AZD1775 and an antimiotic in previsously treated NSCLC patiients | Assessed in terms of adverse events and laboratory data that is collected on all patients | Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity | Yes |
| Secondary | Pharmacokinetic profile of AZD 1775 in combination with an antimitotic | Venous blood samples taken for determination of AZD1775, metabolites of 1775 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 | Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity | Yes |
| Secondary | Compare Objective Response Rate and Disease Control Rate between arms | The objective response rate is defined as the number of the subjects with a confirmed best overall response of CR or PR divided by the number of subjects in the Full Analysis Set (FAS) for whom measureable disease is present at baseline. The disease control rate is defined as the percentage of FAS subjects with a best overall response of CR, PR or SD. | Up to projected 20 months, Subjects will be restaged after every 2 cycles in Part B (every 6 weeks) continue until disease progression or unacceptable toxicity | No |
| Secondary | Assess the duration of response (DoR) and overall survival in each treatment arm | Duration of response is defined as the time from the date of first documented response until the date of documented progression or any cause death. Overall survival is defined as the time from the date of randomization until death due to any cause. | Up to projected 20 months, assessed every 6 weeks continue until disease progression or any cause death | No |
| Secondary | Safety of AZD 1775 in combination with an antimiototic | Assessed in terms of adverse events and laboratory data that is collected on all patients | Up to projected 20 months , at every Visit | Yes |