TriangleNCT06048367 · OUTCOME
PK Parameters Assessment: AUC (ng•h/mL) Profile Assessment of CNSI-Fe(II) of Second Dosage
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- h*ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- 72 h post second dosage (The second dosing occurs 22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)
What was measured
This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The third assessed parameter is area under the concentration-time curve (AUC). AUC of second dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: AUC: Nanograms per hour per milliliter (ng•h/mL)
Analysis population: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.
Groups in this outcome
CNSI-Fe(II) 60 mg
60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an dditional dose may be administered based aon the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
CNSI-Fe(II) 90 mg
90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
| Group | Source count |
|---|---|
| CNSI-Fe(II) 60 mg | 2 |
| CNSI-Fe(II) 90 mg | 3 |
Reported measurements
AUC (0 ~ 72 h)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CNSI-Fe(II) 60 mg | 13002.57 | 3458.25 | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 90 mg | 32017.68 | 34657.49 | Not reported | Not reported | Not reported |
AUC (0 ~ ∞)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CNSI-Fe(II) 60 mg | 14865.68 | 1617.36 | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 90 mg | 33650.19 | 34384.97 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3458.25
- value
- 13002.57
- group Id
- OG001
- spread
- 34657.49
- value
- 32017.68
- title
- AUC (0 ~ 72 h)
- categories
- measurements
- group Id
- OG000
- spread
- 1617.36
- value
- 14865.68
- group Id
- OG001
- spread
- 34384.97
- value
- 33650.19
- title
- AUC (0 ~ ∞)
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- This secondary outcome measure focuses on assessing the pharmacokinetic (PK) profile of CNSI-Fe(II) in patients with advanced solid tumors. Assessment Details: PK Parameters Assessment: This assessment involves the analysis of the drug's absorption, distribution, metabolism, and excretion (ADME) in patients. It will provide insights into how CNSI-Fe(II) behaves in the human body. The third assessed parameter is area under the concentration-time curve (AUC). AUC of second dosage: The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively. Due to the requirement for mean ± SD data presentation, the number of evaluable subjects in 30 mg, 120 mg, 150 mg groups was fewer than two, making SD calculation impossible. Units of Measure: AUC: Nanograms per hour per milliliter (ng•h/mL)
- dispersion Type
- Standard Deviation
- groups
- description
- 60 mg CNSI-Fe(II) 60 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an dditional dose may be administered based aon the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
- id
- OG000
- title
- CNSI-Fe(II) 60 mg
- description
- 90 mg CNSI-Fe(II) 90 mg: The trial comprises a treatment period, including the DLT evaluation period with a duration of 21 days, and a maintenance treatment period. If the subject completes DLT evaluation without intolerable toxicity, an additional dose may be administered based on the investigator's determination of the benefits outweighing the risks. The original protocol planned for three dose groups: 30 mg, 60 mg, and 90 mg. The protocol was amended on March 28, 2024, to add 120 mg and 150 mg dose groups. A single tumor lesion amenable to intratumoral injection will be selected, regardless of tumor size, number, or location. The drug should be administered at the dose specified for the current dose cohort. The injection volume should be adjusted based on the size of the injected lesion.
- id
- OG001
- title
- CNSI-Fe(II) 90 mg
- param Type
- MEAN
- population Description
- The number of patients receiving the second dose in the 30 mg, 60 mg, 90 mg, 120 mg, and 150 mg dose groups was: 1, 2, 3, 1, and 0, respectively.
- reporting Status
- POSTED
- time Frame
- 72 h post second dosage (The second dosing occurs 22~35 days after first dosing. For patient in 30 mg group, 23 days; for patients in 60 mg group, 26 and 22 days; for patients in 90 mg group, 23, 35 and 28 days; for patient in 120 mg group, 28 days.)
- title
- PK Parameters Assessment: AUC (ng•h/mL) Profile Assessment of CNSI-Fe(II) of Second Dosage
- type
- SECONDARY
- unit Of Measure
- h*ng/mL
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Preserved source evidence · Not medical advice