NCT01752920

Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations

A Phase 1/2 Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma With FGFR2 Gene Fusion

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Derazantinib low dose range	Derazantinib was administered orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule.
DRUG	Derazantinib middle dose range	Derazantinib was administered orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule.
DRUG	Derazantinib high dose range	Derazantinib was administered orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule.
DRUG	Derazantinib at recommended phase 2 dose (RP2D)	Derazantinib was administered orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule.

Timeline

• Start date: 2012-12-10
• Primary completion: 2018-08-28
• Completion: 2018-08-28
• First posted: 2012-12-19
• Last updated: 2023-06-05
• Results posted: 2021-10-28

Locations

12 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated drug study