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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT02711137
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INCB057643 — DRUG
    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).
  • Gemcitabine — DRUG
    Standard of Care (SOC) agents
  • Paclitaxel — DRUG
    Standard of Care (SOC) agents
  • Rucaparib — DRUG
    Standard of Care (SOC) agents
  • Abiraterone — DRUG
    Standard of Care (SOC) agents
  • Ruxolitinib — DRUG
    Standard of Care (SOC) agents
  • Azacitidine — DRUG
    Standard of Care (SOC) agents

Study Details

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.

Key Dates

Start date
May 18, 2016
Status verified
Oct 2025
Primary completion
Feb 13, 2019
Completion
Feb 13, 2019

Study Design

Enrollment
137 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • Experimental: 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.
  • Experimental: 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
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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
  • Experimental: 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.
  • Experimental: 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

Primary Outcome 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 ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-3300-
University of CaliforniaLa JollaCalifornia92093-
Sarah Cannon Research Institute at Health OneDenverColorado80218-
Yale UniversityNew HavenConnecticut06510-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Hematology - Oncology Associates of Treasure CoastPort Saint LucieFlorida34952-
University of MichiganAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
Washington UniversitySt LouisMissouri63110-
University of Rochester, Wilmot Cancer CenterRochesterNew York14642-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157-
Oncology Consultants, P.A.HoustonTexas77030-
The Methodist HospitalHoustonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
MultiCare Institute for Research and InnovationTacomaWashington98405-

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University of Alabama· Birmingham, ALUniversity of California· La Jolla, CASarah Cannon Research Institute at Health One· Denver, COYale University· New Haven, CTSylvester Comprehensive Cancer Center· Miami, FLHematology - Oncology Associates of Treasure Coast· Port Saint Lucie, FL

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