Skip to content
Triangle logo TriangleGet started
← Study library

NCT02711137 · REGISTRY CONDITION SEARCH

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2025-10-21

The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (TEAE's).

→

outcome · POSTED

Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay

→

outcome · POSTED

Objective Response Rate (ORR) With INCB057643 in Solid Tumors

→

outcome · POSTED

Cmax: Maximum Observed Plasma Concentration of INCB057643.

→

outcome · POSTED

Tmax: Time to Maximum Plasma Concentration of INCB057643

→

outcome · POSTED

AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643

→

outcome · POSTED

AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy

→

outcome · POSTED

Part 2 - Cmax: Maximum Observed Plasma Concentration of INCB057643.

→

outcome · POSTED

Part 2-Tmax: Time to Maximum Plasma Concentration of INCB057643

→

outcome · POSTED

AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of relapsed or refractory advanced or metastatic malignancies: * Part 1: solid tumors or lymphomas, or hematologic malignancies * Part 2: histologically confirmed disease in specific tumor types * Part 3: advanced solid tumor or hematologic malignancy * Part 4: select advanced solid tumor or hematologic malignancy * For Part 1 and 2, subjects must have progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy) * For Parts 3 and 4, subjects must have progressed following at least 1 line of prior therapy, and the treatment with the select SOC agent is relevant for the specific disease cohort. * Life expectancy \> 12 weeks, for MF subjects in Parts 3 and 4, life expectancy \> 24 weeks * Eastern Cooperative Oncology Group (ECOG) performance status * Parts 1 and 3: 0 or 1 * Parts 2 and 4: 0, 1, or 2 * Willingness to avoid pregnancy or fathering children Exclusion Criteria: * Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count * Inadequate organ function per protocol-specified total bilirubin, AST and ALT, creatinine clearance and alkaline phosphatase. * Receipt of anticancer medications or investigational drugs within protocol-specified intervals * Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant * Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment * Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy * Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval * Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment * Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed * History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful * Type 1 diabetes or uncontrolled Type 2 diabetes * HbA1c of ≥ 8% (all subjects will have HbA1c test at screening) * Any sign of clinically significant bleeding * Coagulation panel within protocol-specified parameters
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm 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
    intervention Names
    1. Drug: INCB057643
    label
    Part1/Treatment Group A : 8mg QD INCB057643
    type
    EXPERIMENTAL
  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
    intervention Names
    1. Drug: INCB057643
    label
    Part1/Treatment Group A : 12mg QD INCB057643
    type
    EXPERIMENTAL
  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
    intervention Names
    1. Drug: INCB057643
    label
    Part1/Treatment Group A : 16mg QD INCB057643
    type
    EXPERIMENTAL
  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
    intervention Names
    1. Drug: INCB057643
    label
    Part1/Treatment Group B : 8mg QD INCB057643
    type
    EXPERIMENTAL
  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.
    intervention Names
    1. Drug: INCB057643
    label
    Part1/Treatment Group B : 12mg QD INCB057643
    type
    EXPERIMENTAL
  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
    intervention Names
    1. Drug: INCB057643
    label
    Part1/Treatment Group C : 8mg QD INCB057643
    type
    EXPERIMENTAL
  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.
    intervention Names
    1. Drug: INCB057643
    label
    Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
    type
    EXPERIMENTAL
  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.
    intervention Names
    1. Drug: INCB057643
    label
    Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
    type
    EXPERIMENTAL
  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
    intervention Names
    1. Drug: INCB057643
    2. Drug: Gemcitabine
    label
    Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
    type
    EXPERIMENTAL
  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.
    intervention Names
    1. Drug: INCB057643
    2. Drug: Paclitaxel
    label
    Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
    type
    EXPERIMENTAL
  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.
    intervention Names
    1. Drug: INCB057643
    2. Drug: Rucaparib
    label
    Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
    type
    EXPERIMENTAL
  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
    intervention Names
    1. Drug: INCB057643
    2. Drug: Abiraterone
    label
    Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part1/Treatment Group A : 12mg QD INCB057643
    2. Part1/Treatment Group A : 16mg QD INCB057643
    3. Part1/Treatment Group A : 8mg QD INCB057643
    4. Part1/Treatment Group B : 12mg QD INCB057643
    5. Part1/Treatment Group B : 8mg QD INCB057643
    6. Part1/Treatment Group C : 8mg QD INCB057643
    7. Part2/Treatment Group A : 12 mg INCB057643 Expansion Cohort
    8. Part2/Treatment Group B : 12 mg INCB057643 Expansion Cohort
    9. Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
    10. Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
    11. Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
    12. Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
    description
    Initial cohort dose of INCB057643 at the protocol-specified starting dose (Part 1), with subsequent dose escalations based on protocol-specific criteria. The recommended treatment group-specific dose(s) will be taken forward into expansion cohorts (Part 2).
    name
    INCB057643
    type
    DRUG
  2. arm Group Labels
    1. Part3/Treatment Group A : 8 mg INCB057643 + Gemcitabine 1000mg
    description
    Standard of Care (SOC) agents
    name
    Gemcitabine
    type
    DRUG
  3. arm Group Labels
    1. Part3/Treatment Group B : 8 mg INCB057643 + Paclitaxel 80mg
    description
    Standard of Care (SOC) agents
    name
    Paclitaxel
    type
    DRUG
  4. arm Group Labels
    1. Part3/Treatment Group C : 8 mg INCB057643 + Rucaparib 600mg
    description
    Standard of Care (SOC) agents
    name
    Rucaparib
    type
    DRUG
  5. arm Group Labels
    1. Part3/Treatment Group D : 8 mg INCB057643 + Abir +Predni
    description
    Standard of Care (SOC) agents
    name
    Abiraterone
    type
    DRUG
  6. arm Group Labels
    1. Part3/Treatment Group E : 8 mg INCB057643 + Ruxolitinib 20mg
    description
    Standard of Care (SOC) agents
    name
    Ruxolitinib
    type
    DRUG
  7. arm Group Labels
    1. Part3/Treatment Group F : 8 mg INCB057643 + Azacitidine 75mg
    description
    Standard of Care (SOC) agents
    name
    Azacitidine
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
137
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
    measure
    Number of Participants With Treatment Emergent Adverse Events (TEAE's).
    time Frame
    From screening through at least 30 days after end of treatment, up to approximately 24 months
secondary Outcomes
  1. description
    An ex vivo assay (utilized in monotherapy only), Measuring Total c-Myc protein expressed from an exogenously added cell line (KMS12BM) to patient plasma, before and after administration of INCB057643.
    measure
    Percent Inhibition of Total Cellular Myc Protein Concentrations Before and After Administration of INCB057643 When Administered as Monotherapy in an Ex-vivo Assay
    time Frame
    PD in plasma at pre-dose and 0.5, 1, 2, 4, 6 and 8 hours postdose, for C1D1 and C1D8, and 24hrs post dose for C1D1
  2. 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 \[complete response (CR) or partial response (PR)\].
    measure
    Objective Response Rate (ORR) With INCB057643 in Solid Tumors
    time Frame
    Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months
  3. description
    Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fasted state.
    measure
    Cmax: Maximum Observed Plasma Concentration of INCB057643.
    time Frame
    Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8
  4. description
    Time to maximum plasma concentration of INCB057643 administered as monotherapy in fasted state
    measure
    Tmax: Time to Maximum Plasma Concentration of INCB057643
    time Frame
    Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1 and C1D8
  5. description
    Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB057643 administered as monotherapy in fasted state
    measure
    AUC0-t: Area Under the Single-dose Plasma Concentration-time Curve of INCB057643
    time Frame
    Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D1
  6. description
    Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fasted state
    measure
    AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
    time Frame
    Predose, 0.5, 1, 2, 4, 6, 8 hours on C1D8
  7. description
    Maximum Observed Plasma Concentration INCB057643 administered as monotherapy in fed state.
    measure
    Part 2 - Cmax: Maximum Observed Plasma Concentration of INCB057643.
    time Frame
    C2D1
  8. description
    Time to maximum plasma concentration of INCB057643 administered as monotherapy in fed state
    measure
    Part 2-Tmax: Time to Maximum Plasma Concentration of INCB057643
    time Frame
    C2D1
  9. description
    Area under the steady-state plasma concentration-time curve over 1 dosing interval from Hour 0 to 24 for QD administration of INCB057643 administered as monotherapy in fed state.
    measure
    AUC0-24: Area Under the Steady-state Plasma Concentration-time Curve of INCB057643 Administered as Monotherapy
    time Frame
    C2D1
Full study description
brief Summary
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.
Source references
references
  1. citation
    Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clin Cancer Res. 2020 Mar 15;26(6):1247-1257. doi: 10.1158/1078-0432.CCR-18-4071. Epub 2019 Sep 16.
    pmid
    31527168
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-4451086e4f4a6c8478b1
      requested nct id
      NCT02711137
      primary nct id
      NCT02711137
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      3d06f376230cb34d7ead47a8aaa55c68185e43b34df0d4952f6875fc900cd0e2
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-4451086e4f4a6c8478b1
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02711137
      occurrences
      1. context exact
        NCT02711137
        end
        11
        exact text
        NCT02711137
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/210/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      29ef161d70f50c7116eb956d91374d5e14796c01286ba8b4ee4af834326361f9
    2. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-944d114bed4cc33b6d87
      requested nct id
      NCT02711137
      primary nct id
      NCT02711137
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      payload sha256
      d10f149d49daf9bf347356030ad739a0b8398e7656e5237859eb1180b759b6d8
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-944d114bed4cc33b6d87
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02711137
      occurrences
      1. context exact
        NCT02711137
        end
        11
        exact text
        NCT02711137
        start
        0
      offset unit
      unicode_code_points
      query cond
      Small Intestine Cancer
      query disease state id
      ds-small-intestine-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      source json pointer
      /studies/21/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      29ef161d70f50c7116eb956d91374d5e14796c01286ba8b4ee4af834326361f9
    3. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-e2d6d92ee7559c416ac2
      requested nct id
      NCT02711137
      primary nct id
      NCT02711137
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
      payload sha256
      43a7d8141bc8eec760819d2fed2722170ebb2b8fa895cf2e9daf1ce6aa8b00af
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-e2d6d92ee7559c416ac2
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02711137
      occurrences
      1. context exact
        NCT02711137
        end
        11
        exact text
        NCT02711137
        start
        0
      offset unit
      unicode_code_points
      query cond
      Ovarian Germ Cell Tumors
      query disease state id
      ds-ovarian-germ-cell-tumors
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-ovarian-germ-cell-tumors-000.json
      source file sha256
      359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
      source json pointer
      /studies/13/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      29ef161d70f50c7116eb956d91374d5e14796c01286ba8b4ee4af834326361f9

    Preserved source evidence · Not medical advice