CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 119 enrolled
Drug / intervention
Derazantinib low dose range +3 moredrug
Likely dose
Derazantinib low dose range 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01752920
NCT01752920Phase 2Completed
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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

Basilea Pharmaceutica·interventional·Posted Dec 19, 2012·Updated Jun 5, 2023

In Brief

A Phase 2 clinical trial evaluating Derazantinib low dose range, Derazantinib middle dose range, and 2 other interventions for Solid Tumor. Completed, enrolled 119 participants across 12 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesItaly, United States
CollaboratorsArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 19, 2012
Enrollment StartDec 10, 2012
Primary CompletionAug 28, 2018
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 13.5 years ago

Interventions

Derazantinib low dose rangedrug

Derazantinib was administered orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule.

Derazantinib middle dose rangedrug

Derazantinib was administered orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule.

Derazantinib high dose rangedrug

Derazantinib was administered orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule.

Derazantinib at recommended phase 2 dose (RP2D)drug

Derazantinib was administered orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule.