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Protocol No. UW14100

Principal Investigator Leal, Ticiana

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title Phase I/II, First-in-Human, Dose-Escalation Study of X-396 in Patients with Advanced Solid Tumors and Expansion Phase in Patients with ALK+ Non-Small Cell Lung Cancer

Objective This research study is being done to evaluate the safety of an investigational drug, X-396, and to determine the best dose to use for future studies.

Treatment "Investigational" means that X-396 has not been approved by the United States Food and Drug Administration (FDA) for use outside of clinical studies. X-396 has not been given to humans before this study .Different genes have been shown to change and affect the development and growth of tumors. Based on laboratory studies, X-396 blocks the effects of at least 2 of these genes (ALK and MET).

Description There are two parts to this study. Part 1 is called dose escalation. Part 1 has been completed. You are asked to enroll in Part 2 where groups of subjects with non-small cell lung cancer will be treated with a daily dose of X-396 that was shown to be tolerated in Part 1. In Part 2 of the study, you will take the study drug once daily. You will be given a supply of the study drug capsules to take on your own at home. You will need to come to the study site at various times for checkups and evaluations. These visits may take between 4-6 hours, depending on what tests are required to be done. On days 1 and 22 of cycle 1, you will be here approximately 10 hours due to the additional PK testing. You will have approximately 20 visits while you are on the study. Click here for more info

Key Eligibility
  • For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations
  • Patients with treated CNS metastases are eligible if they are asymptomatic with respect to the CNS metastases and do not require escalating doses of systemic corticosteroids
  • Patients with treated CNS metastases are eligible if they are asymptomatic with respect to the CNS metastases and do not require escalating doses of systemic corticosteroids
  • ALK-positive patients with untreated CNS lesions may be allowed to enroll in the expansion cohort phase or previously completed dose escalation cohorts as long as the patients are asymptomatic with respect to the CNS metastases and do not require systemic corticosteroids or anticonvulsants, and if they have not received a 2nd generation ALK TKI
  • Up to 5 patients with leptomeningeal disease may be entered in the expansion cohort phase, if they have not received a 2nd generation ALK TKI
  • Patients must have measurable or evaluable disease for the dose escalation portion of the study and measurable disease for the expanded cohort portion of the study
  • Patients must have measurable or evaluable disease for the dose escalation portion of the study and measurable disease for the expanded cohort portion of the study are excluded
  • Patients with any major surgery, radiotherapy, or immunotherapy within the last 21 days (focal radiation is allowed ≥2 weeks prior to the first dose; ≥4 weeks for whole brain radiotherapy) will be excluded
  • Patients with prior stem cell transplant will be excluded
  • Femaes who ar pregnant or breastfeeding are excluded
  • Patients who are immunosuppressed (including known HIV infection), have a serious active infection at the time of treatment, have known hepatitis C, or have any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment are excluded
  • Patients with presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of X-396 will be excluded

Applicable Disease Sites Lung

Therapies Involved Cytotoxic Chemotherapy

Drugs Involved X-396

Status Open

Participating Institutions UW Hospital and Clinics