This is a single-arm, open-label, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of E7090 in patients with advanced or recurrent solid tumors harboring FGFR genetic alterations (including fusion, mutation, amplification).
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants with histologically or cytologically confirmed metastatic, unresectable, or recurrent solid tumor who agree to provide an archival tumor sample, a residual biopsy sample, or a fresh tumor biopsy sample
. Ineffective to or intolerant to initial treatment, or for which standard treatment is no longer available
. Participants with an FGFR gene alteration detected by NGS panel, who fall under one of the categories of groups A to C and E defined as below
. For Group D, participants with cholangiocarcinoma who have previously received a selective FGFR inhibitor other than E7090 and have demonstrated progressive disease or resistance
. Karnofsky Performance Status (KPS) \>= 70 for patients with primary CNS tumors. Performance Status (ECOG) 0-1 for patients with non-primary CNS tumors
. For patients with non-primary CNS tumors, they have at least 1 lesion of \>= 10 millimeter (mm) in the longest diameter for a non-lymph node or \>= 15 mm in the short-axis diameter for a lymph node that is considered as serially measurable according to RECIST v1.1 using computerized tomography or magnetic resonance imaging (CT or MRI) within 28 days of enrollment. However, lesions that have received local treatment such as external-beam radiation therapy (EBRT) or radiofrequency ablation (RFA) must have progressed after these local treatment to count as measurable lesion
. Participants with primary CNS tumors must meet all of the following criteria:
. Have received prior treatment including radiation and/or chemotherapy, as recommended or appropriate for the CNS tumor type
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participants with brain, subdural or leptomeningeal metastases
. Participants with primary CNS tumor located in either cerebellum, brainstem, spinal cord, pituitary gland, optic nerve or olfactory nerve
. Positive for either human immunodeficiency virus (HIV) antibody, HBs antigen, or HCV antibody (patients with positive HCV antibody but no detectable HCV-RNA are not excluded)
. Negative for HBs antigen, but positive for HBs antibody or HBc antibody, and also positive for HBV-DNA quantification (not excluded if HBV-DNA is below detection sensitivity)
. Child-Pugh score B or C
. Participants with pericardial effusion, pleural effusion, or ascites requiring treatment