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A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib (INCB039110) in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02018861
Recruitment Status : Active, not recruiting
First Posted : December 23, 2013
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor, INCB050465, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1 inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. INCB050465 inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.

Condition or disease Intervention/treatment Phase
B-Cell Malignancies Drug: INCB050465 Drug: itacitinib Drug: Rituximab Drug: Ifosfamide Drug: Carboplatin Drug: Etoposide Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib (INCB039110) in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
Study Start Date : March 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: INCB050465
escalating doses given every day (QD)
Drug: INCB050465
Experimental: INCB050465 in combination with itacitinib (INCB039110)
Starting dose of INCB050465 determined in Part 1 of the study in combination with itacitinib (INCB039110)given QD
Drug: INCB050465 Drug: itacitinib
Other Names:
  • INCB039110
  • itacitinib (INCB039110)
Experimental: INCB050465 rituximab, ifosfamide, carboplatin, and etoposide
Starting dose of INCB050465 determined in Part 1 given in combination with: rituximab on Days 1 and 2 of Cycle 1, and Day 1 of Cycles 2 and 3; ifosfamide and carboplatin given on Day 3 of each Cycle; and etoposide given on Days 3 to 5 of each Cycle.
Drug: INCB050465 Drug: Rituximab Drug: Ifosfamide Drug: Carboplatin Drug: Etoposide

Primary Outcome Measures :
  1. Safety and tolerability assessed by summary of Adverse Events (AEs), clinical lab assessments, physical exam results, and 12-lead ECGs for INCB050465 as monotherapy and as a combination therapy [ Time Frame: Measured every 3 weeks for approximately 15 months ]

Secondary Outcome Measures :
  1. Efficacy as measured by overall response rate [ Time Frame: Measured every 9 weeks for approximately 15 months ]
  2. Pharmacokinetic collections to determine Cmax, Tmax, Cmin, half-life [ Time Frame: Measured for each patient at Day 1, Day 8, and Day 15 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 18 years or older, with lymphoid malignancies of B-cell origin including:

    1. Indolent / aggressive B-cell non-Hodgkin's lymphoma (NHL)

      • EXCLUDING: Burkitt's lymphoma and precursor B lymphoblastic leukemia/lymphoma
      • INCLUDING: any non-Hodgkin's B cell malignancy such as chronic lymphocytic leukemia (CLL) and rare non-Hodgkin's B- cell subtypes such as hairy cell leukemia, Waldenström macroglobulinemia (WM), mantle cell leukemia (MCL), and transformed NHL histologies
    2. Hodgkin's lymphoma (HL)
  • Life expectancy of 12 weeks or longer
  • Subject must have received ≥ 1 prior treatment regimen(s)
  • The subject must not be a candidate for potentially curative therapy including hematopoietic stem cell transplantation, except where one of the standard therapy regimen combinations may be used prior to transplantation per standard medical practice

Exclusion Criteria:

  • Has history of brain metastasis, spinal cord compression (unless treated, asymptomatic, and stable on most recent imaging and enrolling in expansion cohort), or lymphoma involving the central nervous system (CNS)
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 3 (≥ 2 during dose escalation)
  • Received allogeneic hematopoietic stem cell transplant within the last 6 months, or has active graft versus host disease (GVHD) following allogeneic transplant, or currently receiving immunosuppressive therapy following allogeneic transplant
  • Received autologous hematopoietic stem cell transplant within the last 3 months
  • Inadequate marrow reserve assessed by hematologic laboratory parameters
  • Inadequate renal or liver function
  • Known HIV infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018861

United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, Florida
Port Saint Lucie, Florida, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, New York
New York, New York, United States
United States, Ohio
Cleveland, Ohio, United States
United States, South Carolina
Greenville, South Carolina, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
Sponsors and Collaborators
Incyte Corporation
Study Director: Claudia Corrado, M.D. Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02018861     History of Changes
Other Study ID Numbers: INCB 50465-101 (CITADEL-101)
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Etoposide phosphate
Isophosphamide mustard
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents