An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellula… (NCT03144661) | Clinical Trial Compass
TerminatedPhase 1
An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies
Stopped: Strategic Business Decision
United States, Belgium25 participantsStarted 2017-05-25
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Part 1: HCC; cholangiocarcinoma; or esophageal, nasopharyngeal, or serious ovarian cancer, regardless of FGF19/FGFR4 status; or other solid tumor malignancies with documented FGF19/FGFR4 alteration (FGF19/FGFR4 pathway activating alterations include, but are not limited to, FGFR4 amplification, FGFR4 activating mutations, and FGF19 amplification) based on local testing.
* 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 FGF19/FGFR4 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.
* Centrally analyzed screening C4 (bile acid synthesis precursor) results must be below 40.9 ng/mL, which is the upper limit as determined by the sponsor.
* Must agree to take bile acid sequestrants while taking INCB062079.
Exclusion Criteria:
* Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medication…
What they're measuring
1
Safety and tolerability of INCB062079 as measured by assessment of adverse events (AEs)
Timeframe: Baseline to 30-35 days after end of treatment, up to approximately 6 months per subject.