NCT02264613 · OUTCOME
Determine Overall Response Rate
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
- From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
What was measured
The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).
Groups in this outcome
Dose Regimen A (DR-A) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
Dose Regimen C (DR-C) PTCL Expansion
Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
| Group | Source count |
|---|---|
| Dose Regimen A (DR-A) PTCL Expansion | 21 |
| Dose Regimen C (DR-C) PTCL Expansion | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Regimen A (DR-A) PTCL Expansion | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Regimen C (DR-C) PTCL Expansion | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- The proportion of efficacy-evaluable patients who achieve complete response (CR) or partial response (PR), per investigator assessment, in accordance with RECIST 1.1 or iRECIST (for solid tumor patients) or Response Assessment in Neuro-Oncology (RANO) criteria (for glioblastoma patients).
- groups
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 8 and 15 of a 28-day cycle. ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG000
- title
- Dose Regimen A (DR-A) PTCL Expansion
- description
- Drug: ALRN-6924 Weight-based-dosing administered IV on days 1, 3 and 5 of a 21-day cycle ALRN-6924: ALRN-6924 will be administered as an IV infusion
- id
- OG001
- title
- Dose Regimen C (DR-C) PTCL Expansion
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- From Day 1 of treatment until 30 days after the last cycle of treatment (each cycle in DR-A is 28 days, DR-B and DR-C is 21 days), an average of 138 Days
- title
- Determine Overall Response Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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