TriangleNCT01088984 · OUTCOME
Recommended Phase II Dose (RP2D) of Bendamustine
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/m^2
- Interval / dispersion
- Not reported
- Time frame
- Induction Cycle (21- to 35-day cycle)
What was measured
RP2D was determined by a traditional 3+3 dose escalation design, with the following restrictions: only doses of 60, 90, 120, and 150 mg/m\^2 were explored, and escalation to 150 mg/m\^2 would only occur if the 120 mg/m\^2 dose was deemed safe and pharmacokinetic data indicate subtherapeutic exposure as compared with adults. The first cohort was administered bendamustine at the 90 mg/m\^2 dose; de-escalation to the 60 mg/m\^2 dose would only occur if the starting dose led to dose-limiting toxicity (DLT) in 2 or more participants. A DLT was defined as any study drug-related nonhematologic adverse event (AE) that was grade 4 for toxicity by National Cancer Institute's Common Toxicity Criteria for AEs, version 4. In addition, grade 3 or above allergic reaction or skin rash were considered DLTs. Hematologic AEs were not considered DLTs. The dose level at which at least 2 of 3 or 2 of 6 participants had a DLT was considered as exceeding the RP2D. The RP2D was the dose 1 step below that level.
Analysis population: All participants enrolled in Phase 1 of the study.
Groups in this outcome
Phase 1: Bendamustine 90 or 120 mg/m^2
Bendamustine 90 or 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
| Group | Source count |
|---|---|
| Phase 1: Bendamustine 90 or 120 mg/m^2 | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Bendamustine 90 or 120 mg/m^2 | 120 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 120
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- RP2D was determined by a traditional 3+3 dose escalation design, with the following restrictions: only doses of 60, 90, 120, and 150 mg/m\^2 were explored, and escalation to 150 mg/m\^2 would only occur if the 120 mg/m\^2 dose was deemed safe and pharmacokinetic data indicate subtherapeutic exposure as compared with adults. The first cohort was administered bendamustine at the 90 mg/m\^2 dose; de-escalation to the 60 mg/m\^2 dose would only occur if the starting dose led to dose-limiting toxicity (DLT) in 2 or more participants. A DLT was defined as any study drug-related nonhematologic adverse event (AE) that was grade 4 for toxicity by National Cancer Institute's Common Toxicity Criteria for AEs, version 4. In addition, grade 3 or above allergic reaction or skin rash were considered DLTs. Hematologic AEs were not considered DLTs. The dose level at which at least 2 of 3 or 2 of 6 participants had a DLT was considered as exceeding the RP2D. The RP2D was the dose 1 step below that level.
- groups
- description
- Bendamustine 90 or 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
- id
- OG000
- title
- Phase 1: Bendamustine 90 or 120 mg/m^2
- param Type
- NUMBER
- population Description
- All participants enrolled in Phase 1 of the study.
- reporting Status
- POSTED
- time Frame
- Induction Cycle (21- to 35-day cycle)
- title
- Recommended Phase II Dose (RP2D) of Bendamustine
- type
- PRIMARY
- unit Of Measure
- mg/m^2
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice