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:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT01130805
Eligibility Criteria:
Inclusion Criteria:
* Subjects who provide written informed consent
* Age over 18 years
* Histologically proven unresectable gastric cancer
* ECOG performance status of 0-2
* At least one uni-dimensionally measurable lesion by RECIST criteria ver 1.1
* Adequate organ system function absolute neutrophil count \> 1,500/µL, platelets \> 100,000/µL, hemoglobin \> 9g/dl Total bilirubin \< 1.5 times upper limit of normal (ULN), AST and ALT \< 2.5 times ULN, PT (INR), PTT \< 1.2 times UNL Serum creatinine less than 1.5 mg/dL or Calculated Ccr at least 50 mL/min, Urine Protein to Creatinine Ratio (UPC) less than 1
* female with Non-childbearing potential
Exclusion Criteria:
* Prior malignancy
* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug
* Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including
* Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
* Presence of uncontrolled infection
* Corrected QT interval (QTc) above 480 msecs using Bazett's formula
* History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting, Myocardial infarction, Unstable angina, Coronary artery bypass graft surgery, Symptomatic peripheral vascular disease, Class II or higher congestive heart failure
* Poorly controlled hypertension while on antihypertensive agents
* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
* Evidence of active bleeding or bleeding diathesis
* Hemoptysis within 6 weeks of first dose of study drug
* Any serious and/or unstable preexisting medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
* Unable or unwilling to discontinue use of prohibited medications listed in the protocol
* Treatment with any of the following anti-cancer therapies;Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib; biologic therapy, immunotherapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib; No prior chemotherapy except adjuvant chemotherapy (Patients who received adjuvant chemotherapy at least 6 months prior to study entry will be allowed regardless of chemotherapeutic regimen
* Pre-existing grade 2 (or higher) motor or sensory neuropathy by CTCAE v4.0
* Known allergy to study drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01130805
Study Brief:
Protocol Section:
NCT01130805