TriangleNCT01915498 · OUTCOME
Phase 1 Dose Expansion: Time to First Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).
What was measured
Time to response is defined as the time from the date of first dose to the date of the first occurrence of response of CR, CRi, CRp, PR, mCR (for MDS) or MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS as assessed by the Investigator.
Analysis population: Participants who received at least one dose of study treatment in Phase 1 Dose Expansion who had an objective response.
Groups in this outcome
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD | 23 |
| Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD | 5 |
| Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD | 9 |
| Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD | 1.9 | Not reported | 0.5 | 9.4 | Not reported |
| Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD | 3.7 | Not reported | 0.9 | 5.5 | Not reported |
| Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD | 1.8 | Not reported | 1.0 | 3.8 | Not reported |
| Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD | 1.4 | Not reported | 0.5 | 9.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 9.4
- value
- 1.9
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 5.5
- value
- 3.7
- group Id
- OG002
- lower Limit
- 1.0
- upper Limit
- 3.8
- value
- 1.8
- group Id
- OG003
- lower Limit
- 0.5
- upper Limit
- 9.2
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 12
- units
- Participants
- description
- Time to response is defined as the time from the date of first dose to the date of the first occurrence of response of CR, CRi, CRp, PR, mCR (for MDS) or MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS as assessed by the Investigator.
- dispersion Type
- Full Range
- groups
- description
- Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG000
- title
- Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
- description
- Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG001
- title
- Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
- description
- Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG002
- title
- Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
- description
- Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG003
- title
- Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
- param Type
- MEDIAN
- population Description
- Participants who received at least one dose of study treatment in Phase 1 Dose Expansion who had an objective response.
- reporting Status
- POSTED
- time Frame
- Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in Phase 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).
- title
- Phase 1 Dose Expansion: Time to First Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice