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Open-Label, Dose-Escalation Study of INCB054828 in Subjects With Advanced Malignancies

This study is currently recruiting participants.
Verified July 2017 by Incyte Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02393248
First Posted: March 19, 2015
Last Update Posted: July 19, 2017
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.
Information provided by (Responsible Party):
Incyte Corporation
  Purpose
The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of INCB054828 in subjects with advanced malignancies. This study will have three parts, dose escalation (Part 1), dose expansion (Part 2) and combination therapy (Part 3).

Condition Intervention Phase
Malignant Solid Tumour Carcinoma, Non-Small-Cell Lung Stomach Neoplasms Urothelial Carcinoma Endometrial Neoplasms Multiple Myeloma MPN Breast Cancer Cholangiocarcinoma Drug: INCB054828 Drug: Gemcitabine+Cisplatin Drug: Pembrolizumab Drug: Docetaxel Drug: Trastuzumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Determination of the maximum tolerated dose of INCB054828 as a monotherapy and in combination as measured by the number of participants with adverse events [ Time Frame: from baseline through 21 days ]
  • Assess the pharmacodynamics of INCB054828 as a monotherapy and in combination as indicated by serum phosphorus level [ Time Frame: up to 30 days (+ 5 days) follow-up visit ]

Secondary Outcome Measures:
  • Preliminary efficacy as assessed by Overall Response Rate (ORR) of INCB054828 as monotherapy and in combination in subjects with measurable disease [ Time Frame: Day 15 of every third cycle (± 2 days) while subjects are on study ]
    Tumor response rates in those subjects with measurable disease as determined by investigator assessment of response using RECIST (Response Evaluation Criteria in Solid Tumor) criteria

  • Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of INCB054828 as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]
    The pharmacokinetic (PK) parameters of Cmax and Cmin will be calculated from the blood plasma concentrations of INCB054828 using standard noncompartmental PK methods.

  • Minimum observed plasma concentration (Cmin) during the dosing interval of INCB054828 as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]
    The pharmacokinetic (PK) parameters of Cmax and Cmin will be calculated from the blood plasma concentrations of INCB054828 using standard noncompartmental PK methods.

  • Time to maximum plasma concentration (Tmax) of INCB054828 as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]
    The PK parameter of Tmax will be calculated from the blood plasma concentrations of INCB054828 using standard noncompartmental PK methods.

  • Area under the single-dose plasma concentration-time curve (AUC0-t) of INCB054828 as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]
    Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, calculated by the linear trapezoidal rule for increasing concentrations and the log trapezoidal rule for decreasing concentrations.

  • Oral dose clearance (Cl/F) of INCB054828 as monotherapy and in combination [ Time Frame: Cycle 1 Day 1, Day 2, Day 8 and Day 15 ]
    The PK parameter of Cl/F will be calculated from the blood plasma concentrations of INCB054828 using standard noncompartmental PK methods.


Estimated Enrollment: 280
Study Start Date: January 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation

Open-label dose escalation with an accelerated titration design based on observing each dose level for a period of 21 days.

Dose Expansion

Combination therapy:

  • Gemcitabine + Cisplatin + INCB054828
  • Pembrolizumab + INCB054828
  • Docetaxel + INCB054828
  • Trastuzumab + INCB054828
Drug: INCB054828 Drug: Gemcitabine+Cisplatin Drug: Pembrolizumab Drug: Docetaxel Drug: Trastuzumab

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Male or female subjects, age 18 years or older on day of signing consent
  2. Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
  3. Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
  4. Life expectancy > 12 weeks
  5. Eastern Cooperative Oncology Group (ECOG) performance status:

    • Part 1: 0 or 1
    • Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

  1. Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
  2. Prior receipt of a selective FGFR inhibitor
  3. History of a calcium/phosphate homeostasis disorder
  4. History and/or current evidence of ectopic mineralization/calcification
  5. Current evidence of corneal disorder/keratopathy
  6. Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
  7. Prior radiotherapy within 2 weeks of study treatment
  Contacts and Locations
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): NCT02393248


Contacts
Contact: Incyte Call Center 1-855-463-3463

Locations
United States, Alabama
University of Alabama Recruiting
Tuscaloosa, Alabama, United States, 35205
United States, California
Cedars Sinai Terminated
Los Angeles, California, United States, 90048
United States, Connecticut
Yale Cancer Center Terminated
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Georgetown University - Lombardi Comprehensive Cancer Center Recruiting
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Hematology - Oncology Associates of Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Signal Point Clinical Research Center Terminated
Middletown, Ohio, United States, 45042
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Denmark
Onkologisk Klinik Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Luis Féliz, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02393248     History of Changes
Other Study ID Numbers: INCB 54828-101
First Submitted: January 30, 2015
First Posted: March 19, 2015
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Incyte Corporation:
alterations in FGF or FGFR
squamous non-small cell lung cancer
gastric cancer
urothelial cancer
endometrial cancer
multiple myeloma
MPN

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Cholangiocarcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Transitional Cell
Stomach Neoplasms
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Adenocarcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases