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Trial record 1 of 1 for:    NCT02998476
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A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02998476
First received: December 13, 2016
Last updated: December 15, 2016
Last verified: December 2016
  Purpose
The purpose of this study is to assess the safety and efficacy of INCB050465 in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: INCB050465
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Objective response rate based on Lugano Classification criteria [ Time Frame: Protocol-defined timepoints throughout the treatment period, up to 42 months ]
    Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014).


Secondary Outcome Measures:
  • Median duration of response [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter, up to 42 months ]
    Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response.

  • Median progression-free survival [ Time Frame: Every 9 weeks through Week 27, then every 18 weeks thereafter, up to 42 months ]
    Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment.

  • Overall survival (OS) [ Time Frame: From randomization every 12 weeks until death due to any cause; up to 42 months ]
  • Safety as assessed by percentage of subjects with adverse events [ Time Frame: Screening through 35 days after end of treatment, up to 42 months ]

Estimated Enrollment: 120
Study Start Date: December 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A INCB050465 (no prior BTK inhibitor)
INCB050465 in subjects who were not previously treated with a BTK inhibitor.
Drug: INCB050465
INCB050465 once daily for 8 weeks followed by once weekly
Experimental: Group B INCB050465 (prior BTK inhibitor)
INCB050465 in subjects who were previously treated with a BTK inhibitor.
Drug: INCB050465
INCB050465 once daily for 8 weeks followed by once weekly

  Eligibility

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

Inclusion Criteria:

  • Eligible 19 years and older in South Korea
  • Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 1 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant.
  • Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or magnetic resonance imaging (MRI).
  • Subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
  • Eastern Cooperative Oncology Group performance status 0 to 2.

Exclusion Criteria:

  • Primary mediastinal (thymic) large B-cell lymphoma.
  • Known brain or central nervous system metastases or history of uncontrolled seizures.
  • Allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months.
  • Use or expected use during the study of any prohibited medications, including potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug.
  • Prior treatment with the following:

    • Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg, ibrutinib).
    • Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a pan PI3K inhibitor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02998476

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

Locations
United States, New York
Recruiting
Lake Success, New York, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Fitzroy Dawkins, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02998476     History of Changes
Other Study ID Numbers: INCB 50465-202/CITADEL-202
Study First Received: December 13, 2016
Last Updated: December 15, 2016

Keywords provided by Incyte Corporation:
Diffuse large B-cell lymphoma
relapsed
refractory
non-Hodgkin lymphoma
phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor
Bruton's tyrosine kinase (BTK)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 25, 2017