Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors

NCT03600233 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: CVM-005
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Oncology; Neuroendocrine Tumors; NET; Vasculogenic mimicry

Outcome Measures

Primary Outcomes (1)

• Time-to progression-free survival (PFS)

  Measure the Time-to PFS or death to any cause. The tumor assessment will be performed every 12 weeks until documented disease progression, death, or date of follow-up.

  12 months after the last patient enrolled

Secondary Outcomes (20)

• Objective response rate (ORR)

  up to 12 months after the last patient enrolled

• Disease control rate (DCR)

  up to 12 months after the last patient enrolled

• Duration of overall response (DoR)

  up to 12 months after the last patient enrolled

• Time-to progression (TTP)

  up to 12 months after the last patient enrolled

• Time-to overall survival (OS)

  up to 12 months after the last patient enrolled

Study Arms (1)

CVM-1118

EXPERIMENTAL

CVM-1118 200mg or 300mg Bis In Die (BID) daily/ Cycle (28 days per cycle)

Drug: CVM-1118

Interventions

CVM-1118 DRUG

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.

Also known as: TRX-818

CVM-1118

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Tumor eligibility\] 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:
• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≦ 3 x upper limit of normal (ULN), or AST and ALT ≦ 5 x ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin ≦ 1.5 x ULN (except for patients with documented Gilbert's syndrome)
• Absolute neutrophil count (ANC) ≧ 1500/µL
• Platelets ≧ 90,000/µL
• Hemoglobin ≧ 9.0 g/dL
• Serum creatinine ≦ 2.0 x ULN or creatinine clearance of ≧ 50 mL/min
• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.

You may not qualify if:

• Patients eligible for this study must not meet ANY of the following criteria:
• Poorly differentiated neuroendocrine carcinoma, or high grade neuroendocrine tumor.
• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
• Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.
• Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.
• Current treatment on another clinical trial.
• 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:
• myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6-month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancer. Appropriate treatment with anticoagulants is permitted.
• Hypertension that cannot be controlled by medications (\> 160/100 mmHg despite optimal medical therapy).
• Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
• Known history of human immunodeficiency virus (HIV) seropositivity and/or is receiving anti-retroviral therapy.
• Hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.
• History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy.

Sponsors & Collaborators

• TaiRx, Inc.: lead

Study Sites (8)

Chang Gung Memorial Hospital, KaoHsiung

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

New Taipei Municipal TuCheng Hospital

New Taipei City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, LinKou

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Adenoma, Islet Cell; Gastro-enteropancreatic neuroendocrine tumor; Carcinoma, Neuroendocrine; Neoplasms

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adenoma; Neoplasms, Glandular and Epithelial; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma

Study Officials

• Wu-Chou Su

  National Cheng Kung University Hospital,Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 26, 2018
• Study Start: December 15, 2018
• Primary Completion: September 30, 2024
• Study Completion: March 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

TW (8)