TriangleNCT01915498 · OUTCOME
Phase 1 Dose Expansion: Investigator Assessed Overall Response Rate (ORR)
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
ORR is defined as the percentage of participants achieving an overall 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. 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) PR: - Meets hematologic criteria of CR - Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: - Bone marrow blasts \< 5% - Absence of blasts with Auer rods - Absence of extramedullary disease - No hematologic recovery required mCR: - Bone marrow myeloblasts ≤ 5% and decreased by ≥ 50%
Analysis population: All participants who received at least one dose of study treatment in Phase 1 Expansion.
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 | 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 QD | 46.9 | Not reported | 32.5 | 61.7 | Not reported |
| Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD | 20.0 | Not reported | 6.8 | 40.7 | Not reported |
| Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD | 36.0 | Not reported | 18.0 | 57.5 | Not reported |
| Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD | 44.4 | Not reported | 25.5 | 64.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 32.5
- upper Limit
- 61.7
- value
- 46.9
- group Id
- OG001
- lower Limit
- 6.8
- upper Limit
- 40.7
- value
- 20.0
- group Id
- OG002
- lower Limit
- 18.0
- upper Limit
- 57.5
- value
- 36.0
- group Id
- OG003
- lower Limit
- 25.5
- upper Limit
- 64.7
- value
- 44.4
- 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
- ORR is defined as the percentage of participants achieving an overall 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. 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) PR: - Meets hematologic criteria of CR - Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: - Bone marrow blasts \< 5% - Absence of blasts with Auer rods - Absence of extramedullary disease - No hematologic recovery required mCR: - Bone marrow myeloblasts ≤ 5% and decreased by ≥ 50%
- 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 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
- NUMBER
- population Description
- All participants who received at least one dose of study treatment in Phase 1 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: Investigator Assessed Overall Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice