Ph II Trial of Carboplatin and Pemetrexed With or Without AZD1775 for Untreated Lung Cancer
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Previously Untreated Stage IV Non-Squamous Non Small Cell Lung Cancer
In brief
The aim of this study is to combine AZD1775 with standard front-line chemotherapy in subjects with advanced NSCLC.
Key facts
- Study ID
- NCT02087241
- Run by
- AstraZeneca
- People needed
- 22
- Starts
- 2014-03-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2017-03-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provision of informed consent prior to any study specific procedures
- Histologic or cytologic diagnosis of advanced NSCLC, Recurrent or Stage IV disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0).
- No prior chemotherapy for locally advanced or metastatic disease
- Subjects with a known EGFR mutation must have received previous treatment with an EGFR tyrosine kinase inhibitor; and subjects with a known ALK translocation must have received previous treatment with an ALK inhibitor.
- No prior radiation therapy to the whole pelvis or to ≥25% of the total bone marrow area.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
- Mandatory availability of tumour tissue (archival or fresh if archival is not available) for TP53 determination.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
- Absolute neutrophil count (ANC) ≥1500/μL
- Hemoglobin (Hgb) ≥10 g/dL
- Platelets ≥100,000/μL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ≤3.0 x the upper limit of normal (ULN); 5 x ULN if known hepatic metastases
- Total bilirubin ≤1.5 x ULN, unless secondary to Gilbert's disease
- Serum creatinine ≤1.5 x ULN and a calculate creatinine clearance (CrCl) ≥45 mL/min by the Cockcroft-Gault method
- 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 who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment
- Predicted life expectancy ≥12 weeks
- Must be ≥18 years of age
- Willingness and ability to comply with study and follow-up procedures
- Ability to understand the nature of this trial and give written informed consent Exclusion criteria
- Use of a study drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of AZD1775
- Major surgical procedures ≤28 days of beginning AZD1775, or minor surgical procedures ≤7 days
- Known central nervous system (CNS) disease
- Subject has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be sensitive CYP3A4 substrates
Where it is running
- Research Site — Englewood, Colorado, United States
- Research Site — Fort Myers, Florida, United States
- Research Site — Orlando, Florida, United States
- Research Site — Peoria, Illinois, United States
- Research Site — Fort Wayne, Indiana, United States
- Research Site — Wichita, Kansas, United States
- Research Site — Cincinnati, Ohio, United States
- Research Site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.