TriangleNCT01457417 · OUTCOME
Progression Free Survival (PFS) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause
What was measured
For Part B only. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (ie, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.
Analysis population: Patients with advanced NSCLC receiving the study drug at 300 mg every 2 weeks in Part B
Groups in this outcome
300 mg DKN-01 Part B (Q2W)
Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
| Group | Source count |
|---|---|
| 300 mg DKN-01 Part B (Q2W) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 300 mg DKN-01 Part B (Q2W) | 2.2 | Not reported | 1.5 | 2.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 2.9
- value
- 2.2
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- For Part B only. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (ie, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
- id
- OG000
- title
- 300 mg DKN-01 Part B (Q2W)
- param Type
- MEDIAN
- population Description
- Patients with advanced NSCLC receiving the study drug at 300 mg every 2 weeks in Part B
- reporting Status
- POSTED
- time Frame
- Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause
- title
- Progression Free Survival (PFS) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice