TriangleNCT03207347 · OUTCOME
Progression-Free Survival Rate at 6 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of subjects
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 6 months
What was measured
Determine the progression-free survival rate at 6 months after study entry in each cohort. This is the percentage of subjects that both have not had disease progression and are alive 6 months after study entry. 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 | 39 | Not reported | 20 | 58 | Not reported |
| Cohort B | 57 | Not reported | 28 | 78 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20
- upper Limit
- 58
- value
- 39
- group Id
- OG001
- lower Limit
- 28
- upper Limit
- 78
- value
- 57
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Determine the progression-free survival rate at 6 months after study entry in each cohort. This is the percentage of subjects that both have not had disease progression and are alive 6 months after study entry. 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
- NUMBER
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Progression-Free Survival Rate at 6 Months
- type
- SECONDARY
- unit Of Measure
- percentage of subjects
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice