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Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors

NCT03600233 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-12-23

No results posted yet for this study

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.

Conditions

  • Neuroendocrine Tumors
  • Pancreatic Neuroendocrine Tumor
  • Gastro-enteropancreatic Neuroendocrine Tumor
  • Lung Neuroendocrine Neoplasm
  • Neuroendocrine Carcinoma

Interventions

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.

Sponsors & Collaborators

  • TaiRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Wu-Chou Su · National Cheng Kung University Hospital,Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2024-09-30
Completion
2026-03-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600233 on ClinicalTrials.gov