TriangleNCT02487095 · OUTCOME
Ph II: Number of Participants With a Clinical Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Every two cycles (each cycle is 21 days) up to approximately 30 months.
What was measured
Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
Analysis population: 1/26 participants was not evaluable for response in the Phase II DL4 SCLC group. Phase II, DL4 Arm/Group is split into two groups for this outcome measure because the distinction is relevant for the phase II, DL4 since extrapulmonary small cell cancers (EPSCC) was an exploratory cohort of the phase II DL4 (added with an amendment).
Groups in this outcome
Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose.
Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV
Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose.
| Group | Source count |
|---|---|
| Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 25 |
| Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 15 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 3 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 6 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 14 | Not reported | Not reported | Not reported | Not reported |
| Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 3
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 6
- title
- Stable Disease
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
- groups
- description
- Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose.
- id
- OG000
- title
- Phase II Dose Level 4 - Small Cell Lung Cancer (SCLC) Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV
- description
- Phase II Dose Level (DL) 4 Topotecan 1.25mg/m\^2 intravenous (IV) (days 1-5); VX970 (M6620) 210mg/m\^2 IV on day 2, 5. Maximum Tolerated Dose/Recommended Phase II Dose.
- id
- OG001
- title
- Phase II DL 4 - Extrapulmonary Small Cell Cancer (EPSCC)Topotecan 1.25mg/m^2 IV/VX970 210mg/m^2 IV
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 1/26 participants was not evaluable for response in the Phase II DL4 SCLC group. Phase II, DL4 Arm/Group is split into two groups for this outcome measure because the distinction is relevant for the phase II, DL4 since extrapulmonary small cell cancers (EPSCC) was an exploratory cohort of the phase II DL4 (added with an amendment).
- reporting Status
- POSTED
- time Frame
- Every two cycles (each cycle is 21 days) up to approximately 30 months.
- title
- Ph II: Number of Participants With a Clinical Response
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice