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Trial record 6 of 8 for:    nut midline carcinoma

A Phase 1/2, Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

This study is currently recruiting participants.
Verified May 2017 by Incyte Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02711137
First Posted: March 17, 2016
Last Update Posted: May 10, 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
This is an open-label, dose-escalation/dose-expansion study of INCB057643 in subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies.

Condition Intervention Phase
Advanced Cancer Drug: INCB057643 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/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Safety and tolerability of INCB057643 as assessed by clinical laboratory assessments, physical examinations, 12 lead ECGs, and adverse events (AEs) [ Time Frame: From screening through at least 30 days after end of treatment, up to approximately 24 months ]

Secondary Outcome Measures:
  • Plasma and urine concentrations of INCB057643 when administered in the fasted state [ Time Frame: Protocol-defined timepoints in treatment Cycle 1, up to approximately 1 month. PK in urine over 8-hour interval postdose ]
  • Plasma concentrations of INCB057643 when administered in the fed state [ Time Frame: Protocol-defined timepoints in treatment Cycles 1 and 2, up to approximately 1 month ]
  • Measurement of cellular myc protein concentrations before and after administration of INCB057643 [ Time Frame: PD in plasma at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose, up to approximately 1 month. Sparse correlative whole blood and plasma up to approximately 6 months ]
  • Efficacy assessed by objective response rate (ORR) per disease-specific response criteria [ Time Frame: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months ]
  • Efficacy assessed by progression-free survival (PFS) per disease-specific response criteria [ Time Frame: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months ]
  • Efficacy assessed by duration of response per disease-specific response criteria [ Time Frame: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months ]
  • Efficacy assessed by overall survival per disease-specific response criteria [ Time Frame: Efficacy measures from screening through end of treatment and follow-up (every 9 weeks), up to approximately 24 months ]

Estimated Enrollment: 230
Study Start Date: May 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB057643 Drug: INCB057643
Initial cohort dose of INCB057643 at the protocol-specified starting dose, with subsequent dose escalations based on protocol-specific criteria. The recommended treatment group-specific dose(s) will be taken forward into expansion cohorts.

  Eligibility

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.


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

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced malignancy:

    • Part 1: advanced solid tumor or hematologic malignancy
    • Part 2: histologically confirmed disease in specific tumor types
  • Progressed following at least 1 line of prior therapy and there is no further established therapy that is known to provide clinical benefit (including subjects who are intolerant to the established therapy)
  • Life expectancy > 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status

    • Part 1: 0 or 1
    • Part 2: 0, 1, or 2
  • Willingness to avoid pregnancy or fathering children

Exclusion Criteria:

  • Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count
  • Inadequate organ function per protocol-specified total bilirubin, AST and ALT, and creatinine clearance
  • Receipt of anticancer medications or investigational drugs within protocol-specified intervals
  • Unless approved by the medical monitor, may not have received an allogeneic hematopoietic stem cell transplant within 6 months before treatment, or have active graft-versus-host-disease following allogeneic transplant
  • Unless approved by the medical monitor, may not have received autologous hematopoietic stem cell transplant within 3 months before treatment
  • Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy
  • Radiotherapy within the 2 weeks before initiation of treatment. Palliative radiation treatment to nonindex or bone lesions performed less than 2 weeks before treatment initiation may be considered with medical monitor approval
  • Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
  • Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
  • History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful
  • Type 1 diabetes or uncontrolled Type 2 diabetes
  • HbA1c of ≥ 8% (all subjects will have HbA1c test at screening)
  • Any sign of clinically significant bleeding
  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): NCT02711137


Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Study Coordinator    205-975-7265      
Principal Investigator: Andres Forero-Torres         
United States, California
University of California Recruiting
La Jolla, California, United States, 92093
Contact: Study Coordinator    858-822-0201      
Principal Investigator: Razelle Kurzrock         
United States, Colorado
Sarah Cannon Research Institute at Health One Recruiting
Denver, Colorado, United States, 80218
Contact: Study Coordinator    720-754-2610      
Principal Investigator: Gerald Falchook         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Study Coordinator    203-671-0785      
Principal Investigator: Patricia LoRusso         
United States, Florida
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Study Coordinator    305-243-9899      
Principal Investigator: Justin Watts         
Hematology - Oncology Associates of Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
Contact: Study Coordinator    772-408-5159      
Principal Investigator: Seth Rosen         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Study Coordinator    734-673-2966      
Principal Investigator: David Smith         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Study Coordinator    612-624-0937      
Principal Investigator: Shilpa Gupta         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Study Coordinator    314-747-1864      
Principal Investigator: Haeseong Park         
United States, New York
University of Rochester, Wilmot Cancer Center Recruiting
Rochester, New York, United States, 14642
Contact: Study Coordinator    585-276-4447      
Principal Investigator: Marcus Noel         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Study Coordinator    984-974-8660      
Principal Investigator: Catherine Coombs         
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Study Coordinator    336-713-3539      
Principal Investigator: Glen Lesser         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Study Coordinator    215-728-2207      
Principal Investigator: Philip Pancari         
United States, Texas
Oncology Consultants, P.A. Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-516-4968      
Principal Investigator: Julio Peguero         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Study Coordinator    713-441-9984      
Principal Investigator: Swaminathan Iyer         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Study Coordinator    801-585-1312      
Principal Investigator: Ignacio Garrido-Laguna         
United States, Washington
MultiCare Institute for Research and Innovation Recruiting
Tacoma, Washington, United States, 98405
Contact: Study Coordinator    253-403-1278      
Principal Investigator: Nathal Massod         
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Fred Zheng, MD, PhD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02711137     History of Changes
Other Study ID Numbers: INCB 57643-101
First Submitted: March 9, 2016
First Posted: March 17, 2016
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Incyte Corporation:
NUT midline carcinoma
Solid tumor
lymphoma
leukemia
AML
myelodysplastic syndrome (MDS)
multiple myeloma
myeloproliferative neoplasm (MPN)
MDS/MPN
myelofibrosis (MF)
pancreatic cancer
colorectal cancer
non-small cell lung cancer
prostate cancer
breast cancer
ovarian cancer
glioblastoma multiforme (GBM)
non-Hodgkin lymphoma
diffuse large B-cell lymphoma (DLBCL)
double-hit
triple-hit
myc
bromodomain and extra-terminal (BET) inhibitor