NCT02535312 · OUTCOME
Number of Subject With Overall 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
- Up to 8 weeks post-treatment
What was measured
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), 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), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR
Groups in this outcome
Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
TRC102 50 mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
| Group | Source count |
|---|---|
| Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I) | 3 |
| Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I) | 4 |
| Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I) | 3 |
| Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I) | 6 |
| Arm B, Dose Level 1 - 50mg TRC102 (Phase II) | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I) | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I) | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B, Dose Level 1 - 50mg TRC102 (Phase II) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 14
- units
- Participants
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), 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), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Overall Response (OR) = CR + PR
- groups
- description
- TRC102 50 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- id
- OG000
- title
- Arm A, Dose Level 1 - 50mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- description
- TRC102 75 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- id
- OG001
- title
- Arm A, Dose Level 2 - 75mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- description
- TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 60 mg/m\^2 IV over 30-60 min day1
- id
- OG002
- title
- Arm A, Dose Level 3 - 100mg TRC102, 60mg/m^2 Cisplatin (Phase I)
- description
- TRC102 100 mg/day PO days 1-4; Pemetrex 500 mg/m\^2 IV over 10 min day1; Cisplatin 75 mg/m\^2 IV over 30-60 min day1
- id
- OG003
- title
- Arm A, Dose Level 4 - 100mg TRC102, 75mg/m^2 Cisplatin (Phase I)
- description
- TRC102 50 mg/day PO on days 1-4; Pemetrex 500mg/m\^2 IV over 10 min day 1
- id
- OG004
- title
- Arm B, Dose Level 1 - 50mg TRC102 (Phase II)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 8 weeks post-treatment
- title
- Number of Subject With Overall Response
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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