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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00697632
Eligibility Criteria:
Inclusion Criteria:
* Advanced metastatic or unresectable malignancy that is refractory to standard therapy and/or existing therapies are not likely to achieve clinical benefit, and/or the patient declines to receive standard treatment such as chemotherapy.
* Evaluable disease;
* Last dose of prior chemotherapy, radiation therapy, or investigational agents occurred at least 4 weeks before the start of therapy;
* Recovery from the adverse effects ≤ grade 1;
* Acceptable ECOG status 0, 1, or 2;
* Life expectancy greater than 3 months following study entry;
* Adequate laboratory values;
* For patients enrolling in the four expansion cohorts:
* NSCLC patients must meet criteria for MET and/or Axl expression or,
* HNSCC patients must meet criteria for MET and/or Axl expression or,
* NSCLC patients must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus or;
* Patients with tumor types such as HNSCC, papillary renal carcinoma, gastric adenocarcinoma, and other solid tumors must meet criteria for amplification of the MET gene locus, defined MET mutations, or rearrangements involving the AXL or MET gene locus
Exclusion Criteria:
* Uncontrolled concurrent illness;
* History of cardiovascular illness;
* QTc \> 470 msec (including subjects on medication);
* Left ventricular ejection fraction (LVEF) \< 50%;
* Immunocompromised subjects;
* History of bone marrow transplant;
* Lung tumor lesions with increased likelihood of bleeding;
* Symptomatic or uncontrolled brain metastases;
* Unable to swallow oral medications or with pre-existing gastrointestinal disorders.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00697632
Study Brief:
Protocol Section:
NCT00697632