TriangleNCT00306202 · OUTCOME
Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/m^2 QD
- Interval / dispersion
- Not reported
- Time frame
- From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
What was measured
The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.
Analysis population: All treated participants: Participants who received at least 1 dose of study therapy
Groups in this outcome
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2, escalated/dose level 3 of 100 mg/m\^2, escalated/dose level 3 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 17 |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 17 |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose | 60 | Not reported | Not reported | Not reported | Not reported |
| Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose | 80 | Not reported | Not reported | Not reported | Not reported |
| Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose | NA | Not reported | Not reported | Not reported | Phase II dose was not chosen for this population as there is no current plan to move forward with development in this population due to lack of efficacy despite escalations to the highest dose of 120 mg/m\^2 in this trial. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 80
- comment
- Phase II dose was not chosen for this population as there is no current plan to move forward with development in this population due to lack of efficacy despite escalations to the highest dose of 120 mg/m\^2 in this trial.
- group Id
- OG002
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 24
- units
- Participants
- description
- The recommended phase 2 dasatinib dose was determined based on efficacy, safety, and pharmacokinetic data obtained at the prespecified dose levels.
- groups
- description
- Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.
- id
- OG000
- title
- Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
- description
- Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
- id
- OG001
- title
- Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
- description
- Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2, escalated/dose level 3 of 100 mg/m\^2, escalated/dose level 3 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
- id
- OG002
- title
- Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose
- param Type
- NUMBER
- population Description
- All treated participants: Participants who received at least 1 dose of study therapy
- reporting Status
- POSTED
- time Frame
- From the date of first dose to end-of-treatment (EOT) (Median duration of therapy in months: Stratum 1=24.11 [Range:2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
- title
- Recommended Phase II Dose of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia
- type
- PRIMARY
- unit Of Measure
- mg/m^2 QD
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Preserved source evidence · Not medical advice