Trials / Active Not Recruiting
Active Not RecruitingNCT03600233
Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors
A Phase II, Open-label Study of CVM-1118 Administered Orally to Patients With Advanced Neuroendocrine Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- TaiRx, Inc. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Neuroendocrine tumors (NETs) are a group of uncommon heterogeneous malignancies originating from neuroendocrine cells localized throughout the body. Approximately 50% of patients with NETs would have metastatic cancer, where 65% of patients with metastatic cancer would result in mortality within 5 years of diagnosis. The current treatments of NETs do not follow single discipline and the effective agents are largely still under clinical investigations. Apparent formation of vasculogenic mimicry (VM) has been reported in at least two types of NETs. Moreover, VM has been found as part of multiple microvascular alterations in mouse models of pancreatic neuroendocrine tumors. Wih the high potential of inhibiting VM formation, CVM-1118 is considered to have therapeutic potentials in treating NET tumors.
Conditions
- Neuroendocrine Tumors
- Pancreatic Neuroendocrine Tumor
- Gastro-enteropancreatic Neuroendocrine Tumor
- Lung Neuroendocrine Neoplasm
- Neuroendocrine Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CVM-1118 | Patients will initially receive CVM-1118 orally twice daily at 200 mg per dose (400 mg total daily dose). Patients who tolerate this dose for at least 2 Cycles will have the option of increasing the dose of CVM-1118 to 300 mg BID (600 mg total daily dose) if specific criteria are met. |
Timeline
- Start date
- 2018-12-15
- Primary completion
- 2024-09-30
- Completion
- 2026-03-31
- First posted
- 2018-07-26
- Last updated
- 2025-12-23
Locations
8 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03600233. Inclusion in this directory is not an endorsement.