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NCT02711137 · OUTCOME

Objective Response Rate (ORR) With INCB057643 in Solid Tumors

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies · Source last updated 2025-10-21

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
Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months

What was measured

Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response \[complete response (CR) or partial response (PR)\].

Analysis population: The efficacy evaluable population included 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part1/Treatment Group A : 8mg QD INCB0576434
Part1/Treatment Group A : 12mg QD INCB0576435
Part1/Treatment Group A : 16mg QD INCB0576438
Part1/Treatment Group B : 8mg QD INCB0576437
Part1/Treatment Group B : 12mg QD INCB0576435
Part1/Treatment Group C : 8mg QD INCB0576431
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort86
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort5
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg1
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg2
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg4
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni3
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg1
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg2

Reported measurements

Solid Tumors

Analysis denominator · Participants

GroupSource count
Part1/Treatment Group A : 8mg QD INCB0576433
Part1/Treatment Group A : 12mg QD INCB0576434
Part1/Treatment Group A : 16mg QD INCB0576436
Part1/Treatment Group B : 8mg QD INCB0576430
Part1/Treatment Group B : 12mg QD INCB0576430
Part1/Treatment Group C : 8mg QD INCB0576430
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort63
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort0
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg1
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg2
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg4
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni3
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg0
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part1/Treatment Group A : 8mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part1/Treatment Group A : 12mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part1/Treatment Group A : 16mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort0Not reportedNot reportedNot reportedNot reported
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg0Not reportedNot reportedNot reportedNot reported
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg1Not reportedNot reportedNot reportedNot reported
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg0Not reportedNot reportedNot reportedNot reported
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni0Not reportedNot reportedNot reportedNot reported
Lymphoma

Analysis denominator · Participants

GroupSource count
Part1/Treatment Group A : 8mg QD INCB0576431
Part1/Treatment Group A : 12mg QD INCB0576431
Part1/Treatment Group A : 16mg QD INCB0576432
Part1/Treatment Group B : 8mg QD INCB0576430
Part1/Treatment Group B : 12mg QD INCB0576430
Part1/Treatment Group C : 8mg QD INCB0576430
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort16
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort0
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg0
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg0
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg0
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni0
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg0
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part1/Treatment Group A : 8mg QD INCB0576431Not reportedNot reportedNot reportedNot reported
Part1/Treatment Group A : 12mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part1/Treatment Group A : 16mg QD INCB0576431Not reportedNot reportedNot reportedNot reported
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort2Not reportedNot reportedNot reportedNot reported
AML

Analysis denominator · Participants

GroupSource count
Part1/Treatment Group A : 8mg QD INCB0576430
Part1/Treatment Group A : 12mg QD INCB0576430
Part1/Treatment Group A : 16mg QD INCB0576430
Part1/Treatment Group B : 8mg QD INCB0576435
Part1/Treatment Group B : 12mg QD INCB0576432
Part1/Treatment Group C : 8mg QD INCB0576430
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort0
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort3
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg0
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg0
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg0
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni0
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg0
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part1/Treatment Group B : 8mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part1/Treatment Group B : 12mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort1Not reportedNot reportedNot reportedNot reported
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg0Not reportedNot reportedNot reportedNot reported
Glioblastoma

Analysis denominator · Participants

GroupSource count
Part1/Treatment Group A : 8mg QD INCB0576430
Part1/Treatment Group A : 12mg QD INCB0576430
Part1/Treatment Group A : 16mg QD INCB0576430
Part1/Treatment Group B : 8mg QD INCB0576430
Part1/Treatment Group B : 12mg QD INCB0576430
Part1/Treatment Group C : 8mg QD INCB0576430
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort7
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort0
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg0
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg0
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg0
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni0
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg0
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort0Not reportedNot reportedNot reportedNot reported
Myelodysplastic Syndrome

Analysis denominator · Participants

GroupSource count
Part1/Treatment Group A : 8mg QD INCB0576430
Part1/Treatment Group A : 12mg QD INCB0576430
Part1/Treatment Group A : 16mg QD INCB0576430
Part1/Treatment Group B : 8mg QD INCB0576431
Part1/Treatment Group B : 12mg QD INCB0576433
Part1/Treatment Group C : 8mg QD INCB0576430
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort0
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort1
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg0
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg0
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg0
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni0
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg0
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part1/Treatment Group B : 8mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part1/Treatment Group B : 12mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort0Not reportedNot reportedNot reportedNot reported
Myelofibrosis

Analysis denominator · Participants

GroupSource count
Part1/Treatment Group A : 8mg QD INCB0576430
Part1/Treatment Group A : 12mg QD INCB0576430
Part1/Treatment Group A : 16mg QD INCB0576430
Part1/Treatment Group B : 8mg QD INCB0576431
Part1/Treatment Group B : 12mg QD INCB0576430
Part1/Treatment Group C : 8mg QD INCB0576430
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort0
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort1
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg0
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg0
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg0
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni0
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg1
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part1/Treatment Group B : 8mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort0Not reportedNot reportedNot reportedNot reported
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg0Not reportedNot reportedNot reportedNot reported
Multiple Myeloma

Analysis denominator · Participants

GroupSource count
Part1/Treatment Group A : 8mg QD INCB0576430
Part1/Treatment Group A : 12mg QD INCB0576430
Part1/Treatment Group A : 16mg QD INCB0576430
Part1/Treatment Group B : 8mg QD INCB0576430
Part1/Treatment Group B : 12mg QD INCB0576430
Part1/Treatment Group C : 8mg QD INCB0576431
Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort0
Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort0
Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg0
Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg0
Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg0
Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni0
Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg0
Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part1/Treatment Group C : 8mg QD INCB0576430Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG006
        value
        0
      5. group Id
        OG008
        value
        0
      6. group Id
        OG009
        value
        1
      7. group Id
        OG010
        value
        0
      8. group Id
        OG011
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        63
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        4
      12. group Id
        OG011
        value
        3
      units
      Participants
    title
    Solid Tumors
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG006
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        16
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    Lymphoma
  3. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        0
      3. group Id
        OG007
        value
        1
      4. group Id
        OG013
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    AML
  4. categories
    1. measurements
      1. group Id
        OG006
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        7
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    Glioblastoma
  5. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG004
        value
        0
      3. group Id
        OG007
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    Myelodysplastic Syndrome
  6. categories
    1. measurements
      1. group Id
        OG003
        value
        0
      2. group Id
        OG007
        value
        0
      3. group Id
        OG012
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    Myelofibrosis
  7. categories
    1. measurements
      1. group Id
        OG005
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    Multiple Myeloma
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      86
    8. group Id
      OG007
      value
      5
    9. group Id
      OG008
      value
      1
    10. group Id
      OG009
      value
      2
    11. group Id
      OG010
      value
      4
    12. group Id
      OG011
      value
      3
    units
    Participants
description
Objective response rate is defined as the proportion of subjects who have an objective response using the applicable disease assessment criteria. ORR was proportion of participants with best overall response \[complete response (CR) or partial response (PR)\].
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
The efficacy evaluable population included all participants enrolled in the study who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months
title
Objective Response Rate (ORR) With INCB057643 in Solid Tumors
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice