TriangleNCT01915498 · OUTCOME
Phase 1 Dose Expansion: Rate of Complete Response and Complete Responses With Incomplete Hematological Recovery (CR/CRi/CRp)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- 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
The percentage of participants achieving a complete response (CR), CR with incomplete neutrophil recovery (CRi), or a CR with incomplete platelet recovery (CRp) based on the 2003 revised IWG criteria for AML or the 2006 modified IWG criteria for MDS, assessed by the investigator. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L)
Analysis population: All participants who received at least one dose of study treatment in Phase 1 Dose Expansion.
Groups in this outcome
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg
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 | 49 |
| Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD | 25 |
| Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD | 25 |
| Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg | 28.6 | Not reported | 16.6 | 43.3 | Not reported |
| Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD | 8.0 | Not reported | 1.0 | 26.0 | Not reported |
| Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD | 24.0 | Not reported | 9.4 | 45.1 | Not reported |
| Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD | 25.9 | Not reported | 11.1 | 46.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.6
- upper Limit
- 43.3
- value
- 28.6
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 26.0
- value
- 8.0
- group Id
- OG002
- lower Limit
- 9.4
- upper Limit
- 45.1
- value
- 24.0
- group Id
- OG003
- lower Limit
- 11.1
- upper Limit
- 46.3
- value
- 25.9
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 27
- units
- Participants
- description
- The percentage of participants achieving a complete response (CR), CR with incomplete neutrophil recovery (CRi), or a CR with incomplete platelet recovery (CRp) based on the 2003 revised IWG criteria for AML or the 2006 modified IWG criteria for MDS, assessed by the investigator. CR: - ANC \> 1.0 x10⁹/L - Platelet count \> 100 x10⁹/L - Bone marrow (BM) blasts \< 5% - Absence of blasts with Auer rods - Independence of red cell transfusions CRi: - All CR criteria except for residual neutropenia (ANC \< 1.0 x 10⁹/L CRp: - All CR criteria except for residual thrombocytopenia (platelet counts \< 100 x 10⁹/L)
- dispersion Type
- 95% Confidence Interval
- 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
- 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
- NUMBER
- population Description
- All participants who received at least one dose of study treatment in Phase 1 Dose Expansion.
- 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: Rate of Complete Response and Complete Responses With Incomplete Hematological Recovery (CR/CRi/CRp)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice