TriangleNCT02711137 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAE's).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From screening through at least 30 days after end of treatment, up to approximately 24 months
What was measured
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Analysis population: All participants enrolled in the study who received at least 1 dose of study drug.
Groups in this outcome
Part1/Treatment Group A : 8mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
Part1/Treatment Group A : 12mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
Part1/Treatment Group A : 16mg QD INCB057643
Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
Part1/Treatment Group B : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
Part1/Treatment Group B : 12mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
Part1/Treatment Group C : 8mg QD INCB057643
Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Ruxolitinib) in Myelofibrosis.
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Azacitidine) in Acute Myeloid Leukemia and Myelodysplastic Syndrome
| Group | Source count |
|---|---|
| Part1/Treatment Group A : 8mg QD INCB057643 | 4 |
| Part1/Treatment Group A : 12mg QD INCB057643 | 5 |
| Part1/Treatment Group A : 16mg QD INCB057643 | 8 |
| Part1/Treatment Group B : 8mg QD INCB057643 | 7 |
| Part1/Treatment Group B : 12mg QD INCB057643 | 5 |
| Part1/Treatment Group C : 8mg QD INCB057643 | 1 |
| Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort | 86 |
| Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort | 5 |
| Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg | 1 |
| Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg | 2 |
| Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg | 4 |
| Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni | 3 |
| Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg | 1 |
| Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part1/Treatment Group A : 8mg QD INCB057643 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part1/Treatment Group A : 12mg QD INCB057643 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part1/Treatment Group A : 16mg QD INCB057643 | 8 | Not reported | Not reported | Not reported | Not reported |
| Part1/Treatment Group B : 8mg QD INCB057643 | 7 | Not reported | Not reported | Not reported | Not reported |
| Part1/Treatment Group B : 12mg QD INCB057643 | 5 | Not reported | Not reported | Not reported | Not reported |
| Part1/Treatment Group C : 8mg QD INCB057643 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort | 86 | Not reported | Not reported | Not reported | Not reported |
| Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
| Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni | 3 | Not reported | Not reported | Not reported | Not reported |
| Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 86
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 86
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
- groups
- description
- Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
- id
- OG000
- title
- Part1/Treatment Group A : 8mg QD INCB057643
- description
- Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
- id
- OG001
- title
- Part1/Treatment Group A : 12mg QD INCB057643
- description
- Initial cohort dose of INCB057643 monotherapy at the protocol specified starting dose in the TGA. Treatment Group A included solid tumors and lymphoma
- id
- OG002
- title
- Part1/Treatment Group A : 16mg QD INCB057643
- description
- Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF
- id
- OG003
- title
- Part1/Treatment Group B : 8mg QD INCB057643
- description
- Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group B (TGB), based on protocol-specific criteria. Treatment Group B included any acute leukemia, HRMDS, MDS/MPN, or MF.
- id
- OG004
- title
- Part1/Treatment Group B : 12mg QD INCB057643
- description
- Initial cohort dose of INCB054763 monotherapy at the protocol-specified cohort escalation treatment group C (TGC), based on protocol-specific criteria. Treatment Group C includes subjects with MM
- id
- OG005
- title
- Part1/Treatment Group C : 8mg QD INCB057643
- description
- Initial cohort dose of INCB054763 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group A (TGA), based on protocol-specific criteria. Part 2 Treatment Group A expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
- id
- OG006
- title
- Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
- description
- Initial cohort dose of INCB057463 monotherapy at the specified RP2D dose selected in Part 1 cohort escalation treatment group B (TGB), based on protocol-specific criteria. Part 2 Treatment Group B expansion included pancreatic adenocarcinoma, castration-resistant prostrate cancer, breast cancer, high grade serious ovarian cancer, glioblastoma multiform, non-hodgkin's lymphoma, ewing's sarcoma, and solid tumor or lymphoma.
- id
- OG007
- title
- Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
- description
- Initial cohort dose of INCB057643 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Gemcitabine) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies where Gemcitabine is relevant
- id
- OG008
- title
- Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
- description
- Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Paclitaxel) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
- id
- OG009
- title
- Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
- description
- Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Rucaparib) in relapsed or refractory advanced or metastatic solid tumors and hematologic malignancies.
- id
- OG010
- title
- Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
- description
- Initial cohort dose of INCB054763 monotherapy based on protocol-specific criteria. Part 3 will determine the MTD and/or a tolerated dose of the combination of INCB057643 and one of the SOC agents (Abiraterone + Prednisone) in Castration Resistant Prostrate Cancer
- id
- OG011
- title
- Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
- param Type
- NUMBER
- population Description
- All participants enrolled in the study who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From screening through at least 30 days after end of treatment, up to approximately 24 months
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAE's).
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice