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A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762447
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: INCB086550 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
Actual Study Start Date : December 10, 2018
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : August 12, 2021

Arm Intervention/treatment
Experimental: INCB086550 Drug: INCB086550
Part 1: INCB086550 once or twice daily with dose modifications based on tolerability criteria. Part 2 and Part 3: Recommended doses from Part 1.




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events [ Time Frame: Baseline through 90 days after end of treatment, estimated up to 12 months. ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.


Secondary Outcome Measures :
  1. Cmax of INCB086550 in fasted and food effect conditions [ Time Frame: Approximately 1 month ]
    Maximum observed plasma or serum concentration.

  2. tmax of INCB086550 in fasted and food effect conditions [ Time Frame: Approximately 1 month ]
    Time to maximum concentration.

  3. AUC0-tau of INCB086550 in fasted and food effect conditions [ Time Frame: Approximately 1 month ]
    Area under the plasma or serum concentration-time curve from time = 0 to the end of dosing period at steady state

  4. AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions [ Time Frame: Approximately 1 month ]
    Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity

  5. t½ of INCB086550 [ Time Frame: Approximately 1 month ]
    Apparent terminal-phase disposition half-life.

  6. λz of INCB086550 [ Time Frame: Approximately 1 month ]
    Apparent terminal-phase disposition rate constant

  7. CL/F of INCB086550 [ Time Frame: Approximately 1 month ]
    Apparent oral dose clearance.

  8. Vz/F of INCB086550 [ Time Frame: Approximately 1 month ]
    Apparent oral dose volume of distribution.

  9. Pharmacokinetic/pharmacodynamics association of INCB086550 exposure with expression levels of PD-L1 [ Time Frame: Approximately 1 month ]
    Evaluation of the ability of INCB086550 to modulate PD-L1 expression levels as assessed by flow cytometry protein analyses.

  10. Objective response rate [ Time Frame: Every 8 weeks for the duration of study participation; estimated to be 12 months. ]
    Defined as the percentage of participants having complete response (CR) or partial response (PR) by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  11. Disease control rate [ Time Frame: Every 8 weeks for the duration of study participation; estimated to be 12 months. ]
    Defined as the percentage of participants having CR, PR, or stable disease ≥ 12 weeks by investigator assessment of radiographic disease assessments per RECIST v1.1.

  12. Duration of response [ Time Frame: Every 8 weeks for the duration of study participation; estimated to be 12 months. ]
    Defined as the time from the first documented evidence of CR or PR until the earliest date of disease progression by investigator assessment per RECIST v1.1 or death due to any cause, if occurring sooner than progression.

  13. Cmin of INCB086550 in fasted and food effect condiitons [ Time Frame: Approximately 1 month ]
    Minimum observed plasma or serum concentration of INCB086550



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  • Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1 that are considered nonamenable to surgery or other curative treatments or procedures. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable per RECIST v1.1 if progression has been demonstrated in the lesion.
  • Willingness to undergo a tumor biopsy to obtain tumor tissue,Pretreatment and on-treatment tumor biopsies are required.
  • Must have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to or ineligible for standard treatment. There is no limit to the number of prior treatment regimens.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • Life expectancy > 12 weeks.
  • Willingness to avoid pregnancy or fathering children.
  • Part 2 Expansion Cohort 2-A only: Participants with any type of solid tumor that has a local regulatory approval for an anti-PD-1 therapy. Other tumor types may be enrolled with medical monitor approval. Participants must have had confirmed disease progression on a prior anti-PD-1 monoclonal antibody.
  • Part 2 Expansion Cohort 2-B only: Participants with select solid tumors who are immunotherapy-naïve.
  • Part 3 MSI-H or dMMR Expansion Cohort only (Enrolled ex-United States only): Participants with any MSI-H or dMMR solid tumor who are immunotherapy-naïve.

Exclusion Criteria:

  • Laboratory values not within the Protocol-defined range.
  • Clinically significant cardiac disease.
  • History or presence of an ECG that, in the investigator's opinion, is clinically meaningful.
  • Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed. Participants who have previously treated and clinically stable brain or CNS metastases and have not required steroids for at least 7 days before study treatment are eligible.
  • Known additional malignancy that is progressing or requires active treatment.
  • Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
  • Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
  • Active infection requiring systemic therapy.
  • Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
  • Known history of HIV (HIV 1/2 antibodies).
  • Known hypersensitivity or severe reaction to any component of study drug or formulation components.
  • Prior receipt of an anti-PD-L1 therapy for all participants.

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): NCT03762447


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
United States, Pennsylvania
The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kevin O'Hayer, MD, PhD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03762447    
Other Study ID Numbers: INCB 86550-102
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
solid tumors
Additional relevant MeSH terms:
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Neoplasms