Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT00513435
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
* Persistent, recurrent, or metastatic disease that is not amenable to curative-intent therapy with surgery or radiation
* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan
* Karnofsky performance status ≥ 60%
* White blood cell (WBC) ≥ 3,000/mcL
* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin \> 9 g/dL
* Total bilirubin within upper institutional limits of normal (ULN)
* Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Creatinine within ULN OR creatinine clearance ≥ 60 mL/min
* Patients must agree to use adequate birth control for the duration of study participation and for at least 8 weeks after discontinuation of study drug
* May have received 1 prior cytotoxic chemotherapy regimen for recurrent or metastatic disease
Exclusion Criteria:
* Known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
* Urine protein: creatinine ratio ≥ 1.0 OR 24-hour urine protein ≥ 1,000 mg
* QTc prolongation ≥ 480 msecs
* Intercurrent symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* History of myocardial infarction within the past year
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breastfeeding women
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
* Pulmonary fibrosis ≥ grade 2, pleural effusion (non-malignant) ≥ grade 2, or pneumonitis/pulmonary infiltrates ≥ grade 2
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
* Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Use of specifically prohibited cytochrome P450 3A4 (CYP3A4)-active agents or substances
* Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
* Patients receiving any other investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00513435
Study Brief:
Protocol Section:
NCT00513435