TriangleNCT02657889 · OUTCOME
Phase 2: Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
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
- Up to 40 weeks
What was measured
ORR is defined as the percentage of participants with a confirmed best overall response of Complete Response (CR) or Partial Response (PR), RECIST v1.1 for target lesions as assessed by the Investigator. CR is defined as disappearance of all target lesions, Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
Analysis population: Full Analysis Set comprised of all Phase 2 participants who received any amount of study treatment. Only those participants with data available at specified time points were analyzed. .
Groups in this outcome
Phase 2 OC: Niraparib 200mg + Pembrolizumab
Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Phase 2 OC: Niraparib 200mg + Pembrolizumab | 53 |
| Phase 2 TNBC: Niraparib 200mg + Pembrolizumab | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 OC: Niraparib 200mg + Pembrolizumab | 15.1 | Not reported | 7.7 | 25.6 | Not reported |
| Phase 2 TNBC: Niraparib 200mg + Pembrolizumab | 18.2 | Not reported | 10.2 | 28.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.7
- upper Limit
- 25.6
- value
- 15.1
- group Id
- OG001
- lower Limit
- 10.2
- upper Limit
- 28.9
- value
- 18.2
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- ORR is defined as the percentage of participants with a confirmed best overall response of Complete Response (CR) or Partial Response (PR), RECIST v1.1 for target lesions as assessed by the Investigator. CR is defined as disappearance of all target lesions, Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Phase 2 OC: Niraparib 200mg + Pembrolizumab
- description
- Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
- param Type
- NUMBER
- population Description
- Full Analysis Set comprised of all Phase 2 participants who received any amount of study treatment. Only those participants with data available at specified time points were analyzed. .
- reporting Status
- POSTED
- time Frame
- Up to 40 weeks
- title
- Phase 2: Objective Response Rate (ORR) as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice