TriangleNCT04711135 · OUTCOME
Pharmacokinetics (PK) Parameter: Tmax - Based on Blood Radioactivity Concentration Data
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hr
- Interval / dispersion
- Full Range
- Time frame
- Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
What was measured
A comparative assessment of PK will be performed between Observed and Predicted adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study. The observed PK metrics were calculated using non-compartmental analysis (NCA), the predicted PK metrics were derived based on the adolescent population pharmacokinetics (popPK) model.
Analysis population: The PK Analysis Set (PKAS) consisted of all participants who had at least one valid (i.e., not flagged for exclusion) PK measurement. Original NETTER-P protocol intended to conduct separate analyses for the GEP-NET and the PPGL populations. However, the protocol was amended to allow combined analyses for PK across the two patient indications.
Groups in this outcome
GEP-NET and PPGL
All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) and Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
| Group | Source count |
|---|---|
| GEP-NET and PPGL | 11 |
Reported measurements
Observed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GEP-NET and PPGL | 0.58 | Not reported | 0.5 | 0.77 | Not reported |
Predicted
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GEP-NET and PPGL | 0.5 | Not reported | 0.5 | 0.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 0.77
- value
- 0.58
- title
- Observed
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 0.7
- value
- 0.5
- title
- Predicted
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- A comparative assessment of PK will be performed between Observed and Predicted adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study. The observed PK metrics were calculated using non-compartmental analysis (NCA), the predicted PK metrics were derived based on the adolescent population pharmacokinetics (popPK) model.
- dispersion Type
- Full Range
- groups
- description
- All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) and Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
- id
- OG000
- title
- GEP-NET and PPGL
- param Type
- MEDIAN
- population Description
- The PK Analysis Set (PKAS) consisted of all participants who had at least one valid (i.e., not flagged for exclusion) PK measurement. Original NETTER-P protocol intended to conduct separate analyses for the GEP-NET and the PPGL populations. However, the protocol was amended to allow combined analyses for PK across the two patient indications.
- reporting Status
- POSTED
- time Frame
- Up to 72 hours after the first Lutetium [Lu 177] dotatate dose
- title
- Pharmacokinetics (PK) Parameter: Tmax - Based on Blood Radioactivity Concentration Data
- type
- SECONDARY
- unit Of Measure
- hr
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice