TriangleNCT06048367 · OUTCOME
PK Parameters Assessment: Serum Iron Concentration at 15 Min of First Dosage
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- concentration (ng/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- at 15 min of a time frame of 72 h
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 fifth assessed parameter is serum iron concentration. Serum iron concentration at 15 min of first dosage Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)
Groups in this outcome
CNSI-Fe(II) 30 mg
30 mg CNSI-Fe(II) 30 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.
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 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.
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.
CNSI-Fe(II) 120 mg
120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
CNSI-Fe(II) 150 mg
150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
| Group | Source count |
|---|---|
| CNSI-Fe(II) 30 mg | 3 |
| CNSI-Fe(II) 60 mg | 4 |
| CNSI-Fe(II) 90 mg | 6 |
| CNSI-Fe(II) 120 mg | 3 |
| CNSI-Fe(II) 150 mg | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CNSI-Fe(II) 30 mg | 6553.00 | 6514.03 | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 60 mg | 4269.67 | 1870.56 | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 90 mg | 3076.50 | 3019.85 | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 120 mg | 8343.67 | 10921.80 | Not reported | Not reported | Not reported |
| CNSI-Fe(II) 150 mg | 13338.33 | 16864.40 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 6514.03
- value
- 6553.00
- group Id
- OG001
- spread
- 1870.56
- value
- 4269.67
- group Id
- OG002
- spread
- 3019.85
- value
- 3076.50
- group Id
- OG003
- spread
- 10921.80
- value
- 8343.67
- group Id
- OG004
- spread
- 16864.40
- value
- 13338.33
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- group Id
- OG004
- 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 fifth assessed parameter is serum iron concentration. Serum iron concentration at 15 min of first dosage Units of Measure: Nanograms per milliliter (ng/mL) (serum iron ion concentrations changes from baseline)
- dispersion Type
- Standard Deviation
- groups
- description
- 30 mg CNSI-Fe(II) 30 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
- OG000
- title
- CNSI-Fe(II) 30 mg
- 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 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) 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
- OG002
- title
- CNSI-Fe(II) 90 mg
- description
- 120 mg CNSI-Fe(II) 120 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
- id
- OG003
- title
- CNSI-Fe(II) 120 mg
- description
- 150 mg CNSI-Fe(II) 150 mg: The dosing regimen is the same as that for the 30 mg, 60 mg, and 90 mg dose groups. Additionally, if a single lesion cannot accommodate the full corresponding dose of the investigational drug, additional lesions may be selected for simultaneous injection. When multiple lesions are injected, the drug distribution should be allocated proportionally according to the size of each lesion or determined based on the investigator's assessment of an appropriate distribution.
- id
- OG004
- title
- CNSI-Fe(II) 150 mg
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- at 15 min of a time frame of 72 h
- title
- PK Parameters Assessment: Serum Iron Concentration at 15 Min of First Dosage
- type
- SECONDARY
- unit Of Measure
- concentration (ng/mL)
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Preserved source evidence · Not medical advice