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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Derazantinib was administered orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule.
Derazantinib was administered orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule.
Derazantinib was administered orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule.
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Karmanos Cancer Institute, Detroit
Detroit, Michigan, United States
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs)
Adverse events were graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CTCAE is classifying AEs and their associated severity from Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences) to Grade 5 (Death related to AE)
Time frame: 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)
Proportion of Patients With an Objective Tumor Response Per RECIST 1.1
The number of patients with an objective tumor response, which included those with either a complete response (CR) or a partial response (PR) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response. The objective response rate (ORR) was defined as the proportion of patients with a CR or PR.
Time frame: Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated.
Proportion of Patients With Disease Control Per RECIST 1.1
The number of patients with tumor disease control, which included those with either a complete or partial tumor response, or a stable disease (SD) based on RECIST v1.1 guidelines which defines criteria for the radiological assessment in tumor response. The disease control rate (DCR) was defined as the proportion of patients with CR, PR or SD.
Time frame: Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated.
Progression-free Survival (PFS)
PFS was calculated as the time from the date of first dose until documented radiographic disease progression or death from any cause, whichever occurred first. Disease progression is measured according to a specified radiologic increase in tumor size.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Derazantinib was administered orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule.
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Montefiore-Einstein Center for Cancer Care
The Bronx, New York, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
University of Washington
Seattle, Washington, United States
Istituto Clinico Humanitas
Milan, Italy
Istituto Nazionale Tumori (National Cancer Institute)
Milan, Italy
...and 2 more locations
Time frame: Assessments were performed at Baseline, and every 8 weeks during continuous drug administration until the End of Treatment visit (7 [+3] days after the last dose of derazantinib) or as otherwise clinically indicated.