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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

119

Participants

Timeline

Start Date

December 10, 2012

Primary Completion Date

August 28, 2018

Study Completion Date

August 28, 2018

Conditions
Solid Tumor
Interventions
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.

Trial Locations (12)

10467

Montefiore-Einstein Center for Cancer Care, The Bronx

19104

University of Pennsylvania Hospital, Philadelphia

20089

Istituto Clinico Humanitas, Milan

20133

Istituto Nazionale Tumori (National Cancer Institute), Milan

30322

Emory University, Winship Cancer Institute, Atlanta

35128

Instituto Oncologico Veneto, IRCCS, Padua

48201

Karmanos Cancer Institute, Detroit, Detroit

56126

Azienda Ospedaliero-Universitaria Pisana - U.O. Oncologia Medica 2 Univ., Pisa

78229

START - South Texas Accelerated Research Therapeutics, LLC, San Antonio

85258

Scottsdale Healthcare Research Institute, Scottsdale

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

98109

University of Washington, Seattle

Sponsors
All Listed Sponsors
collaborator

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

INDUSTRY

lead

Basilea Pharmaceutica

INDUSTRY