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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 : Active, not recruiting
First Posted : December 23, 2013
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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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

Study Design
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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)
Study Start Date : March 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020
Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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
Birmingham, Alabama, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Claudia Corrado, M.D. Incyte Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02018861     History of Changes
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: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neoplasms
Carboplatin
Rituximab
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Antineoplastic Agents
Antineoplastic Agents, Immunological
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