Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR … (NCT01752920) | Clinical Trial Compass
CompletedPhase 1/2
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
United States119 participantsStarted 2012-12-10
Plain-language summary
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR genetic aberrations, including iCCA with FGFR2 gene fusion (Part 2; Expanded Cohort, signal finding).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed written informed consent granted
✓. Men or women ≥18 years of age
✓. Histologically or cytologically confirmed, locally advanced, inoperable, or metastatic solid tumors. Patients eligible for enrollment in the Expanded Cohort must have documented and/or confirmed FGFR genetic aberrations, including iCCA with FGFR2 gene fusion.
✓. Failure to respond to standard therapy, or for whom standard therapy does not exist.
✓. Evaluable or measurable disease
✓. Archival and/or fresh biopsy tissue samples must be available prior to the first dose of the study drug
✓. Life expectancy ≥ 12 weeks
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion criteria
✕. Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks or five times of the drug half life, whichever is longer, of the first dose of derazantinib
✕. Major surgery or radiation therapy within four weeks of the first dose of derazantinib
✕. Previous treatment with FGFR inhibitors
✕. History of allergic reactions attributed to compounds of similar chemical or biological composition as derazantinib
What they're measuring
1
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs)
Timeframe: Adverse events were collected and reported from the time of receiving first dose of derazantinib to the end of study assessment and follow-up period (30-day post-treatment)
✕. Unable or unwilling to swallow the complete daily dose of derazantinib
✕. Clinically unstable central nervous system (CNS) metastasis
✕. History of myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association classification within 6 months of the first dose of derazantinib (MI occurring \>6 months of the first dose of derazantinib will be permitted)
✕. Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of derazantinib (e.g. Crohn's disease, ulcerative colitis, extensive gastric resection)