An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies



Status:Recruiting
Conditions:Ovarian Cancer, Liver Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:May 25, 2017
End Date:April 2021
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies

The purpose of this study is to evaluate the safety and tolerability, and determine the
maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and
other malignancies.


Inclusion Criteria:

- Part 1: HCC; cholangiocarcinoma; or esophageal, nasopharyngeal, or serous ovarian
cancer, regardless of FGF/FGFR status.

- Part 2: Subjects will be enrolled into 1 of 3 cohorts:

- Cohort A: HCC with FGF19 amplification.

- Cohort B: HCC without FGF19 amplification.

- Cohort C: cholangiocarcinoma, esophageal, nasopharyngeal or serous ovarian
cancers (regardless of FGF/FGFR status), or other solid tumor malignancies with
documented FGF19/FGFR4 alteration.

- Has progressed after prior therapy and either a) there is no further effective
standard anticancer therapy available (including subject refusal) or b) is intolerant
to standard anticancer therapy.

- Life expectancy > 12 weeks.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Part 1) or 0-2
(Part 2).

- Archival tumor specimen according to protocol-defined criteria.

- Screening bile acid (C4) results must be below the central laboratory ULN.

- Must agree to take cholestyramine while taking INCB062079.

Exclusion Criteria:

- Treatment with other investigational study drug for any indication for any reason, or
receipt of anticancer medications within 28 days before first dose of study drug;
subjects must have recovered from AEs due to previously administered therapies.

- Prior receipt of a selective FGFR4 inhibitor within the last 6 months.

- Laboratory parameters outside the protocol-defined ranges.

- History or presence of an abnormal ECG that in the investigator's opinion is
clinically meaningful.

- Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is
permitted for palliative radiation to non- central nervous system (CNS) disease with
medical monitor approval.

- History of human immunodeficiency virus infection.

- Untreated brain or CNS metastases or brain/CNS metastases that have progressed.
Subjects with previously treated and clinically stable brain/CNS metastases and who
are off all corticosteroids for ≥ 4 weeks are eligible.

- Chronic or current active infectious disease requiring systemic antibiotic,
antifungal, or antiviral treatment, except concomitant antiviral systemic therapy for
chronic hepatitis B or C.

- Child-Pugh liver function Class B or C.

- History of clinically significant or uncontrolled cardiac disease.

- History of allergic reactions to INCB062079, any of the excipients of INCB062079 or
similar compounds.

- Pregnant or nursing women or subjects expecting to conceive or father children within
the projected duration of the study, starting with the screening visit through 90 days
after last dose of study drug.

- Any medical condition that would in the investigator's judgment interfere with full
participation in the study, including administration of study medication and attending
required study visits; pose a significant risk to the subject; or interfere with
interpretation of study data.
We found this trial at
6
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: David Smith, MD
Phone: 800-865-1125
University of Michigan The University of Michigan was founded in 1817 as one of the...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Safi Shahda, MD
Phone: 888-600-4822
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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Birmingham, Alabama 35294
Principal Investigator: Mansoor Saleh, MD
Phone: 205-975-8222
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Birmingham, AL
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Brussels,
Principal Investigator: Alain Hendlisz
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Brussels,
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: James Harding, MD
Phone: 212-639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Principal Investigator: Daniel Ahn, MD
Phone: 800-446-2279
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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