TriangleNCT06390852 · OUTCOME
6-month Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined
What was measured
Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
Analysis population: Eligible, treated and mutation status confirmed
Groups in this outcome
Treatment (Larotrectinib [LOXO-101])
Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
| Group | Source count |
|---|---|
| Treatment (Larotrectinib [LOXO-101]) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Larotrectinib [LOXO-101]) | 83.3 | Not reported | 65.6 | 100 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 65.6
- upper Limit
- 100
- value
- 83.3
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
- id
- OG000
- title
- Treatment (Larotrectinib [LOXO-101])
- param Type
- NUMBER
- population Description
- Eligible, treated and mutation status confirmed
- reporting Status
- POSTED
- time Frame
- Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined
- title
- 6-month Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice