TriangleNCT00704730 · OUTCOME
Biochemical Response Calcitonin (CTN) %
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- % participants
- Interval / dispersion
- Not reported
- Time frame
- Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.
What was measured
For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject's time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of \>50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of \>50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.
Analysis population: Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT.
Groups in this outcome
XL184 (Cabozantinib)
XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
Placebo
Oral capsules once daily
| Group | Source count |
|---|---|
| XL184 (Cabozantinib) | 217 |
| Placebo | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| XL184 (Cabozantinib) | 22.6 | 60.71 | Not reported | Not reported | Not reported |
| Placebo | 0.9 | 115.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 60.71
- value
- 22.6
- group Id
- OG001
- spread
- 115.4
- value
- 0.9
- denoms
- counts
- group Id
- OG000
- value
- 217
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- For each on-treatment tumor marker assessment from each subject, the biochemical response of CTN was determined based on percent increase or decrease from baseline. Best biochemical response over course of treatment was determined from evaluation of subject's time point response data. Biochemical response criteria: Complete Response (CR) - decrease in tumor marker into normal range from baseline value; Partial Response (PR) - decrease of \>50% from baseline value when baseline value is above normal range; Stable Disease (SD) - no more than a 50% increase and no more than a 50% decrease from baseline value above normal range; Progressive Disease (PD) - increase of \>50% from baseline value when baseline value is above normal range / or increase from low or normal range at baseline to above normal range; Not Evaluable (NE) - missing baseline value / or baseline value is not elevated and response is not PD / or response can not be determined due to change in assay format.
- groups
- description
- XL184 175 mg L-malate salt weight; 138 mg freebase equivalent weight, oral capsules once daily
- id
- OG000
- title
- XL184 (Cabozantinib)
- description
- Oral capsules once daily
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Population was intent to treat (ITT), randomized to either XL184 or placebo. For the CTN measure the analysis population differs from the ITT population of 219 XL184 and 111 Placebo. Three subjects did not provide samples for CTN. The biomarker analysis was based on available samples, not on ITT.
- reporting Status
- POSTED
- time Frame
- Serum tumor markers CTN evaluated from blood samples collected at screening and every 12 weeks (±5 days from randomization) until date of first documented progression or date of death from any cause, whichever came first, assessed for up to 34 months.
- title
- Biochemical Response Calcitonin (CTN) %
- type
- SECONDARY
- unit Of Measure
- % participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice