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

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ClinicalTrials.gov Identifier: NCT02018861
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : May 4, 2021
Sponsor:
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, parsaclisib, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1 inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. Parsaclisib inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.

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

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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 Iitacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
Actual Study Start Date : September 22, 2016
Actual Primary Completion Date : April 12, 2021
Actual Study Completion Date : April 12, 2021

Arm Intervention/treatment
Experimental: Parsaclisib
escalating doses given every day (QD)
Drug: Parsaclisib
Other Name: INCB050465

Experimental: Parsaclisib in combination with itacitinib (INCB039110)
Starting dose of parsaclisib determined in Part 1 of the study in combination with itacitinib (INCB039110)given QD
Drug: Parsaclisib
Other Name: INCB050465

Drug: Itacitinib
Other Names:
  • INCB039110
  • itacitinib (INCB039110)

Experimental: Parsaclisib rituximab, ifosfamide, carboplatin, and etoposide
Starting dose of parsaclisib 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: Parsaclisib
Other Name: 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 Parsaclisib 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Locations
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United States, Alabama
University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35205
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Nyu Langone Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, South Carolina
Greenville Health System Cancer Institute
Greenville, South Carolina, United States, 29605
United States, Texas
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Claudia Corrado, M.D. Incyte Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02018861    
Other Study ID Numbers: INCB 50465-101 (CITADEL-101)
Parsaclisib ( Other Identifier: Incyte Corporation )
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neoplasms
Rituximab
Carboplatin
Etoposide
Ifosfamide
Antineoplastic Agents, Immunological
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