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Trial record 5 of 15 for:    INCB039110

A Study of INCB039110 in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2016 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02760485
First received: May 2, 2016
Last updated: July 13, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to evaluate the safety/tolerability and efficacy of INCB039110 in combination with ibrutinib in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: INCB039110
Drug: ibrutinib
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1/2 Study of INCB039110 in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Phase 1: Safety and tolerability as assessed by adverse events and changes in clinical and laboratory assessments [ Time Frame: Screening through 35 days after end of treatment, up to 6 months ] [ Designated as safety issue: Yes ]
  • Phase 2: Efficacy as assessed by objective response rate (ORR) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ] [ Designated as safety issue: No ]
    Defined as percentage of subjects achieving a complete or partial response based on radiographic assessment.


Secondary Outcome Measures:
  • Efficacy as assessed by duration of response (DOR) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ] [ Designated as safety issue: No ]
    Defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

  • Efficacy as assessed by progression-free survival (PFS) [ Time Frame: Weeks 8, 16, and every 16 weeks thereafter, up to 6 months ] [ Designated as safety issue: No ]
    Defined as date of enrollment to earliest date of disease progression based on radiographic assessment or death due to any cause.

  • Efficacy as assessed by overall survival (OS) [ Time Frame: Every 12 weeks, up to 6 months ] [ Designated as safety issue: No ]
    Defined as date of enrollment until death due to any cause.


Estimated Enrollment: 78
Study Start Date: September 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB039110 + ibrutinib Drug: INCB039110
Phase 1 will evaluate INCB039110 at the protocol-specified starting dose, with a possible increase or decrease depending on tolerability. Phase 2 will evaluate the recommended dose determined in Phase 1.
Drug: ibrutinib

  Eligibility

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

Inclusion Criteria:

  • Histologically documented diagnosis of DLBCL.

    • Phase 1: any DLBCL subtype.
    • Phase 2: activated B-cell or unclassifiable subtypes confirmed by immunohistochemistry using the Hans algorithm
  • Relapsed or refractory DLBCL, defined as having received at least 1 but no more than 3 prior treatment regimens and ineligible for high-dose chemotherapy/autologous stem cell transplant.
  • Fluorodeoxyglucose-avid disease (based on local evaluation) per the Lugano Classification. Fluorodeoxyglucose-avid disease is defined as disease with a 5-point scale score of 4 or 5.
  • Archived tumor tissue (block or 15-20 unstained slides) available, or be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy (or, in less accessible lymph nodes, 4 to 8 core biopsies).
  • At least 1 measurable (≥ 2 cm in longest dimension) lesion on CT scan or magnetic resonance imaging (MRI).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

  • Transformed DLBCL or DLBCL with coexistent histologies (eg, follicular or mucosa-associated lymphoid tissue lymphoma).
  • Primary mediastinal (thymic) large B-cell lymphoma.
  • Known central nervous system lymphoma (either primary or metastatic).
  • Allogeneic stem cell transplant within the previous 6 months, or active graft versus host disease following allogeneic transplant.
  • Use of immunosuppressive therapy within 28 days of starting study treatment. Immunosuppressive therapy includes but is not limited to cyclosporine A, tacrolimus, or high-dose corticosteroids. Subjects receiving corticosteroids must be at a dose level ≤ 20 mg/day within 7 days of initiating study treatment.
  • Prior or concurrent therapy with a Janus kinase inhibitor, Bruton's tyrosine kinase inhibitor, or lenalidomide (Phase 2 only)
  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: NCT02760485

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Fitzroy Dawkins, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02760485     History of Changes
Other Study ID Numbers: INCB 39110-206 
Study First Received: May 2, 2016
Last Updated: July 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Diffuse large B-cell lymphoma
Relapsed Diffuse large B-cell lymphoma
Refractory Diffuse large B-cell lymphoma
activated B cell
germinal center B-cell
non-Hodgkin lymphoma
JAK1 inhibitor
Bruton's tyrosine kinase (BTK) inhibitor

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 December 07, 2016