Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors (NCT03600233) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors
Taiwan34 participantsStarted 2018-12-15
Plain-language summary
CVM-1118 (TRX-818) is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human is evaluated from the phase 1 study. The objectives of the phase 2 study is to further investigate the efficacy of CVM-1118 for patients with advanced neuroendocrine tumors.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. \[Tumor eligibility\] Histologically or cytologically confirmed advanced (unresectable and/or metastatic) neuroendocrine tumors that are well-differentiated, low or intermediate grade (WHO Grade 1 or 2) of pancreatic or gastrointestinal, or low/ intermediate grade of lung origin, that are refractory to standard of care therapy, or for whom no standard of care therapy is available.
✓. Patients must have measurable or evaluable disease as per RECIST criteria v1.1. Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy.
✓. Patients must have documented progressive disease within 6 months prior enrollment after prior therapy.
✓. Patients who are on therapy with a somatostatin analog are eligible but progressive disease must be demonstrated subsequent to establishment for at least 3 months of a stable dose.
✓. Male or female, 20 years of age or older.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
✓. Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade 1 (except alopecia).
✓. Adequate organ function as defined by the following criteria:
Exclusion criteria
✕. Poorly differentiated neuroendocrine carcinoma, or high grade neuroendocrine tumor.
✕. Patients who are using other investigational agents or who had received investigational drugs within 4 weeks prior to study enrollment.
✕. Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.
✕. Any of the following within the 12 months prior to starting study treatment: