TriangleNCT03207347 · 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
- 95% Confidence Interval
- Time frame
- 8 months
What was measured
Determine the median progression-free survival. Progression-free survival is defined as the duration of time from study entry to time of progression or death or the date of last contact, whichever occurs first. Progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.
Groups in this outcome
Cohort A
This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
Cohort B
This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
| Group | Source count |
|---|---|
| Cohort A | 23 |
| Cohort B | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A | 2.1 | Not reported | 1.8 | 9.1 | Not reported |
| Cohort B | 7.2 | Not reported | 1.8 | 12.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 9.1
- value
- 2.1
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 12.5
- value
- 7.2
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Determine the median progression-free survival. Progression-free survival is defined as the duration of time from study entry to time of progression or death or the date of last contact, whichever occurs first. Progression is defined by RECIST v1.1 criteria and is defined as an increase of at least 20% in the sum of the largest diameters of target lesions and/or the appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
- id
- OG000
- title
- Cohort A
- description
- This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
- id
- OG001
- title
- Cohort B
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- 8 months
- title
- Progression-Free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice