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Trial record 1 of 1 for:    INCB 50465-204
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A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)

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: NCT03144674
Recruitment Status : Active, not recruiting
First Posted : May 9, 2017
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE May 5, 2017
First Posted Date  ICMJE May 9, 2017
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE June 27, 2017
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
Objective response rate based on Lugano Classification criteria [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
Defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by independent review committee (IRC) assessment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Duration of response [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response.
  • Complete response rate based on Lugano Classification criteria. [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the percentage of participants with a CR as determined by an IRC.
  • Progression-free survival [ Time Frame: Up to approximately 39 months ]
    Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression or death from any cause.
  • Overall survival [ Time Frame: Up to approximately 39 months ]
    Defined as the time from the date of the first dose of study treatment until death from any cause.
  • Best percentage change from baseline in target lesion size [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Target lesion size is measured by the sum of the product of diameters of all target lesion sizes.
  • Safety of Parsaclisib as measured by adverse events (AEs) [ Time Frame: Baseline through 30-35 days after end of treatment, up to approximately 15 months per participant. ]
    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2017)
  • Duration of response [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response.
  • Complete response rate based on Lugano Classification criteria. [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Defined as the percentage of participants with a CR as determined by an IRC.
  • Progression-free survival [ Time Frame: Up to approximately 39 months ]
    Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression or death from any cause.
  • Overall survival [ Time Frame: Up to approximately 39 months ]
    Defined as the time from the date of the first dose of study treatment until death from any cause.
  • Best percentage change from baseline in target lesion size [ Time Frame: Protocol-defined timepoints throughout the study, up to approximately 15 months per participant. ]
    Target lesion size is measured by the sum of the product of diameters of all target lesion sizes.
  • Safety of INCB050465 as measured by adverse events (AEs) [ Time Frame: Baseline through 30-35 days after end of treatment, up to approximately 15 months per participant. ]
    An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
Official Title  ICMJE A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
Brief Summary The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Drug: Parsaclisib
Parsaclisib at the protocol-defined dose.
Other Name: INCB050465
Study Arms  ICMJE
  • Experimental: Cohort 1- Closed to Further enrollment
    Participants who have received prior ibrutinib.
    Intervention: Drug: Parsaclisib
  • Experimental: Cohort 2
    Participants who have not received a prior BTK inhibitor.
    Intervention: Drug: Parsaclisib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 20, 2019)
109
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2017)
120
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women, aged 18 or older (except in South Korea, aged 19 or older).
  • Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes.
  • Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter.
  • Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
  • Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
  • Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

  • Evidence of diffuse large B-cell transformation.
  • History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
  • Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
  • Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
  • Active graft versus host disease.
  • Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   France,   Germany,   Israel,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03144674
Other Study ID Numbers  ICMJE INCB 50465-204 (CITADEL-204)
Parsaclisib ( Other Identifier: Incyte Corporation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Claudia Corrado, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP