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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT01095120
Eligibility Criteria:
Primary inclusion criteria:
* Confirmed diagnosis of adenocarcinoma of the stomach or esophagogastric junction
* Measurable disease (revised RECIST; Version 1.1) based on computed tomography
* Eastern Cooperative Oncology Group performance status 0 or 1
* Treatment with only 1 prior regimen (as first-line therapy) and that regimen included a fluoropyrimidine and/or a platinum analogue
* Documented disease progression within 4 months of the last dose of the 1 prior regimen
* Adequate bone marrow, hepatic, and renal function, as defined in the protocol
* At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy, with an approved or investigational agent
* Ability to swallow an oral solid-dosage form of medication
Primary exclusion criteria:
* Nonmeasurable disease only (revised RECIST; Version 1.1)
* History or presence of brain metastasis or leptomeningeal disease
* Operable gastric cancer or operable cancer of the esophagogastric junction
* Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the patient's usual number of bowel movements on at least 2 days within the 14 days prior to enrollment
* Uncontrolled nausea or vomiting within the 14 days prior to enrollment despite the administration of standard antiemetic therapy
* Known malabsorptive disorder
* Significant medical disease other than cancer, as defined in the protocol
* Presence of neuropathy \> Grade 1 (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]; Version 4.0)
* Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
* Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01095120
Study Brief:
Protocol Section:
NCT01095120