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Derazantinib low dose range

Phase 1

Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jun 5, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment119
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01752920Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic AlterationsPHASE1 COMPLETED 119 — — Dec 10, 2012Aug 28, 2018Jun 5, 202312 United States, Italy
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Study Endpoints
Primary Endpoints
Number of Patients With Drug-related Treatment-emergent Adverse Events (TEAEs)
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)

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)

Secondary Endpoints
Proportion of Patients With an Objective Tumor Response Per RECIST 1.1
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
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)
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.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low Dose GroupEXPERIMENTALPatients who received derazantinib orally at dose levels from 25 mg every other day (QOD) - 200 mg daily (QD) on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Middle Dose GroupEXPERIMENTALPatients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
High Dose GroupEXPERIMENTALPatients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Expanded Cohort GroupEXPERIMENTALPatients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria.
Interventions
NameTypeDescription
Derazantinib low dose rangeDRUGDerazantinib was administered orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule.
Derazantinib middle dose rangeDRUGDerazantinib was administered orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule.
Derazantinib high dose rangeDRUGDerazantinib 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)DRUGDerazantinib was administered orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: 1. Signed written informed consent granted 2. Men or women ≥18 years of age 3. 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 ...

Countries:United StatesItaly
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