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A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03688152
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE December 3, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 6 months ]
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03688152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Cmax of INCB053914 in combination with INCB050465 [ Time Frame: Day 15 ]
    Maximum observed plasma concentration.
  • Tmax of INCB053914 in combination with INCB050465 [ Time Frame: Day 15 ]
    Time to maximum plasma concentration.
  • Cmin of INCB053914 in combination with INCB050465 [ Time Frame: Day 15 ]
    Minimum observed plasma concentration during the dosing interval.
  • AUC0-t of INCB053914 in combination with INCB050465 [ Time Frame: Day 15 ]
    Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.
  • Cl/F of INCB053914 in combination with INCB050465 [ Time Frame: Day 15 ]
    Oral dose clearance.
  • Overall response rate [ Time Frame: Up to approximately 6 months ]
    Defined as the percentage of participants with a complete remission (CR)/complete metabolic response (CMR) or partial remission (PR)/partial metabolic response (PMR) as defined by investigator assessment per revised Lugano classification criteria for lymphomas.
  • Duration of response [ Time Frame: Up to approximately 6 months ]
    Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression or death from any cause among participants who achieve an objective response, as determined by radiographic disease assessment.
  • Progression-free survival [ Time Frame: Up to approximately 6 months ]
    Defined as the time from the date of the first dose of any study drug until the earliest date of disease progression, as determined by radiographic disease assessment, or death from any cause, whichever occurs first.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Tolerability Study of INCB053914 in Combination With INCB050465 in Diffuse Large B-Cell Lymphoma
Official Title  ICMJE A Phase 1b, Multicenter, Open-Label Study of the Safety and Tolerability of INCB053914 in Combination With INCB050465 in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Brief Summary The purpose of this study is to evaluate the safety and tolerability of INCB053914 in combination with INCB050465 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
Intervention  ICMJE
  • Drug: INCB053914

    Dose Escalation: INCB053914 at the protocol-defined starting dose in combination with INCB050465, with dose modifications based on tolerability criteria.

    Dose Expansion: Recommended dose from the dose-escalation study.

  • Drug: INCB050465

    Dose Escalation: INCB050465 at the protocol-defined starting dose in combination with INCB053914, with dose modifications based on tolerability criteria.

    Dose Expansion: Recommended dose from the dose-escalation study.

Study Arms  ICMJE Experimental: INCB053914 + INCB050465
INCB053914 in combination with INCB050465.
Interventions:
  • Drug: INCB053914
  • Drug: INCB050465
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior systemic treatment regimens (eg, an anti-CD20 antibody, an anti-CD20 antibody with or without chemotherapy, or chemotherapy alone) and ineligible for further treatment with standard of care.
  • Willing to undergo pretreatment and on-treatment incisional or excisional biopsy of nontarget adenopathy or extranodal lesions. Provision of the most recent, available archived tumor biopsy may satisfy the pretreatment biopsy.
  • Measurable disease as defined by the Lugano classification criteria:

    • ≥ 1 measurable nodal lesion (≥ 1.5 cm in longest dimension) or ≥ 1 measurable extranodal lesion (> 1 cm in longest dimension) on CT scan or MRI
    • ≥ 1 PET-avid lesion.
  • Eastern Cooperative Oncology Group performance status 0 to 2.
  • Willingness to avoid pregnancy or fathering children based on protocol-defined the criteria.

Exclusion Criteria:

  • Laboratory values outside the protocol-defined range at screening unless approved by the medical monitor.
  • Primary mediastinal (thymic) large B-cell lymphoma or Richter's Syndrome.
  • Known brain or central nervous system metastases or history of uncontrolled seizures.
  • Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
  • 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 before the date of the first dose of study treatment.
  • Use of immunosuppressive therapy following allogenic transplant within 28 days of the first dose of study treatment.
  • Prior treatment with a PIM inhibitor, selective PI3Kδ inhibitor (eg, idelalisib), or a pan-PI3K inhibitor.
  • Receipt of anticancer medications, therapies, or investigational drugs within protocol-defined intervals before the date of the first dose of study treatment.
  • Current or previous other malignancy within 3 years of study entry, except cured (or treated with curative intent and no evidence of disease) basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
  • History of liver function abnormality requiring investigation and/or treatment (eg, due to excessive alcohol or drug-induced liver injury).
  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment, and exposure to a live vaccine within 30 days of study treatment administration.
  • Known HIV infection.
  • Evidence of HBV or HCV infection.
  • History of stroke or intracranial hemorrhage within 6 months of the date of study treatment administration.
  • History of clinically significant or uncontrolled cardiac disease.
  • Presence of an abnormal ECG that is clinically meaningful. Screening QTc interval > 480 milliseconds is excluded (corrected by Fridericia).
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
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: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03688152
Other Study ID Numbers  ICMJE INCB 53914-102
Has Data Monitoring Committee No
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: Fred Zheng, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date June 2019

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