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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT04014257
Eligibility Criteria:
Inclusion Criteria(partial):
* Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
* At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1 or Response Assessment in Neuro-Oncology(RANO)
* Relapse after or refractory to systemic drug therapy to malignancy, at least one regimen of cytotoxic chemotherapy, kinase inhibitors including tyrosine kinase inhibitors or immunotherapy which is considered as standard of care if there is no standard regimen recommended, then no experience of systemic drug therapy is acceptable
* Patients with primary central nervous system(CNS) tumors or metastasis, if they have been neurologically stable
* Symptoms should be under control by stable dose of glucocorticoids and analgesic drugs for symptom control at least 2 weeks prior to starting the treatment
* Stable dose of glucocorticoids and analgesic drugs for symptom control should be maintained throughout the study
* Subjects should be off from radiotherapy for at least 14 days prior to the start of study treatment(C1D1) without symptom aggravation
Exclusion Criteria(partial):
* Prior high-dose chemotherapy requiring hematopoietic stem cell transplantation
* History or evidence of suspicious leptomeningeal disease
* Previous surgery of gastrectomy, gastrostomy or any medical condition which interferes with oral ingestion of capsule
* Indwelling percutaneous drainage of bile and chest tube
* Evidence of or suspicious symptomatic spinal cord compression, unless appropriately treated and neurologically stable off glucocorticoid for at least 2 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04014257
Study Brief:
Protocol Section:
NCT04014257