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

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ClinicalTrials.gov Identifier: NCT03762447
Recruitment Status : Not yet recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
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

Study Type : Interventional
Estimated Enrollment : 57 participants
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
Estimated 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 daily at the protocol-defined starting dose, with dose modifications based on tolerability criteria. Part 2: 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 [ Time Frame: Approximately 1 month ]
    Maximum observed plasma or serum concentration.

  2. tmax of INCB086550 [ Time Frame: Approximately 1 month ]
    Time to maximum concentration.

  3. Cmin of INCB086550 [ Time Frame: Approximately 1 month ]
    Minimum observed plasma or serum concentration over the dose interval.

  4. AUC0-t of INCB086550 [ Time Frame: Approximately 1 month ]
    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

  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.



Information from the National Library of Medicine

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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 if progression has been demonstrated in the lesion.
  • 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.

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.

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
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
United States, Florida
Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
United States, Pennsylvania
The University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute Not yet recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Kevin O'Hayer, MD, PhD Incyte Corporation

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

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