2018-12-15
2024-09-30
2025-12-31
34
NCT03600233
TaiRx, Inc.
TaiRx, Inc.
INTERVENTIONAL
Study of CVM-1118 for Patients With Advanced Neuroendocrine Tumors
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-06-07 | N/A | 2024-11-24 |
2018-07-24 | N/A | 2024-11-26 |
2018-07-26 | N/A | 2024-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: CVM-1118 CVM-1118 200mg or 300mg Bis In Die (BID) daily/ Cycle (28 days per cycle) | DRUG: CVM-1118
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), based on the investigator's assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1. | up to 12 months after the last patient enrolled |
| Disease control rate (DCR) | DCR is defined as the proportion of patients with a best overall response of CR, PR, or Stable Disease (SD), based on the investigator's assessment per RECIST criteria v1.1. | up to 12 months after the last patient enrolled |
| Duration of overall response (DoR) | DoR is measured only for the responder subset: patients with confirmed CR or PR based on the investigator's assessment. It is the elapsed time between the date of first documented response and the following date of event defined as the first documented disease progression or death due to underlying cancer, per RECIST criteria v1.1. | up to 12 months after the last patient enrolled |
| Time-to progression (TTP) | TTP is defined as the duration of time from initiation of study medication to first documentation of tumor progression. | up to 12 months after the last patient enrolled |
| Time-to overall survival (OS) | OS is defined as the duration of time from initiation of study medication to death due to any cause. | up to 12 months after the last patient enrolled |
| Number of participants with treatment-related adverse events (AEs) as assessed by CTCAE v4.03 | Assessment of adverse events will based on the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]. | During the course of the trial or within 28 days following termination from the trial |
| Number of Participants With Abnormal baseline and out-of range Hematology Count by CTCAE v4.03 | Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided. | From baseline of screening up to end of treatment or withdraw, an average of 12 months |
| Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range urinalysis test by CTCAE v4.03 | Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. A list of all laboratory normal ranges will also be provided. | From baseline of screening up to end of treatment or withdraw, an average of 12 months |
| Number of Participants With Abnormal Laboratory Values_Assessed the baseline and out-of range coagulation test by CTCAE v4.03 | Normal range of PT/PTT will be provided. Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal laboratory values would be provided. | From baseline of screening up to end of treatment or withdraw, an average of 12 months |
| Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ body temperature by CTCAE v4.03 | Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided. | From baseline of screening up to end of treatment or withdraw, an average of 12 months |
| Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ blood pressure by CTCAE v4.03 | Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided. | From baseline of screening up to end of treatment or withdraw, an average of 12 months |
| Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ heart rate by CTCAE v4.03 | Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided. | From baseline of screening up to end of treatment or withdraw, an average of 12 months |
| Number of Participants With Abnormal Vital Sign_Assessed the baseline and out-of-range vital signs_ respiratory rate by CTCAE v4.03 | Values with CTCAE v4.03 Grade ≧ 3 will be identified with flags. A final outcome result with the number of participants with abnormal vital sign would be provided. Normal ranges will also be provided. | From baseline of screening up to end of treatment or withdraw, an average of 12 months |
| Abnormalities in electrocardiography (ECG) | a 12-lead (with a 10-second rhythm strip) tracing, with a capacity to calculate the standard intervals automatically, will be used. | From baseline of screening up to end of treatment or withdraw, an average of 12 months |
| Maximum Plasma Concentration [Cmax] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing | PK parameters will be calculated for CVM-1118 and its metabolite CVM-1125 during this study. | Cycle 1 and Cycle 2 (each cycle is 28 days) |
| Area Under the Curve [AUC] of CVM-1118 and its metabolite CVM-1125 after CVM-1118 dosing | PK parameters will be calculated for CVM-1118 and its metabolite CVM-1125 during this study. | Cycle 1 and Cycle 2 (each cycle is 28 days) |
| Pharmacodynamics analysis for the relationship of Cmax and PFS | The correlations of PK parameter, Cmax and key efficacy endpoint will be evaluated in this study. | Cycle 1 and Cycle 2 (each cycle is 28 days) |
| Pharmacodynamics analysis for the relationship of AUC and PFS | The correlations of PK parameter, AUC and key efficacy endpoint will be evaluated in this study. | Cycle 1 and Cycle 2 (each cycle is 28 days) |
| Pharmacodynamics analysis for the relationship of AUC and AE | The correlations of PK parameter, AUC and key safety endpoint will be evaluated in this study. | Cycle 1 and Cycle 2 (each cycle is 28 days) |
| Pharmacodynamics analysis for the relationship of Cmax and AE | The correlations of PK parameter, Cmax and key safety endpoint will be evaluated in this study. | Cycle 1 and Cycle 2 (each cycle is 28 days) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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