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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT02478866
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed, locally advanced, or metastatic solid tumor that progressed, or failed to respond to, at least one prior systemic therapy
* Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
* Life expectancy ≥3 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Adequate bone marrow, hepatic, and renal function
* Patients of child bearing potential must agree to take contraception during the study and for 90 days after the last day of treatment
* Signed Informed Consent Form
Exclusion Criteria:
* Prior treatment with agents of HGF/c-Met inhibitors or HGF/c-Met antibody(Including Crizotinib,Cabozantinib,Volitinib etc.)
* Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 4 weeks prior to initiation of study treatment
* History of organ transplant; had surgery or severe injury within 4 weeks
* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 2, except for alopecia
* Any evidence of severe or uncontrolled systemic diseases, including CTCAE 3 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease
* Pregnant (positive pregnancy test) or lactating women
* Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
* Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance
* Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
* Inability to comply with study and follow-up procedures
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02478866
Study Brief:
Protocol Section:
NCT02478866