NCT06390852 · OUTCOME
Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- 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
What was measured
PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. 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.
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]) | 14.4 | Not reported | 8.5 | NA | 90% CI upper bound not reached |
Complete source fields
- classes
- categories
- measurements
- comment
- 90% CI upper bound not reached
- group Id
- OG000
- lower Limit
- 8.5
- upper Limit
- NA
- value
- 14.4
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. 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.
- 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
- MEDIAN
- 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
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice
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