Derazantinib and Atezolizumab in Patients With Urothelial Cancer

Part of paid clinical trials in Newnan, Georgia.

Sponsor
Basilea Pharmaceutica
Study ID
NCT04045613
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Derazantinib 300 mg once daily monotherapy — DRUG
    Derazantinib was administered orally at a dose of 300 mg once daily
  • Derazantinib 200 mg once daily + atezolizumab 1200 mg — DRUG
    Derazantinib was administered orally at a dose of 200 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
  • Derazantinib 300 mg once daily+ atezolizumab 1200 mg — DRUG
    Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
  • Derazantinib 200 mg twice daily + atezolizumab 1200 mg — DRUG
    Derazantinib was administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every 3 weeks
  • Derazantinib 300 mg once daily monotherapy (QD) — DRUG
    Derazantinib was administered orally at a dose of 300 mg once daily
  • Derazantinib 300 mg once daily + atezolizumab 1200 mg — DRUG
    Derazantinib was administered orally at a dose of 300 mg once daily in combination with atezolizumab 1200 mg every 3 weeks
  • Derazantinib 200 mg twice daily monotherapy — DRUG
    Derazantinib was administered orally at a dose of 200 mg twice daily

Study Details

The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

Key Dates

Start date
Aug 2, 2019
Status verified
Sep 2023
Primary completion
Oct 4, 2022
Completion
Oct 4, 2022

Study Design

Enrollment
95 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Substudy 1: Derazantinib 300 mg once daily
    Patients with urothelial cancer were treated with derazantinib 300 mg once daily
  • Experimental: Substudy 2 (Dose-Level 1): Derazantinib 200 mg once daily + atezolizumab 1200 mg
    Patients with any solid tumors were treated with derazantinib 200 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as intravenous (IV) infusion
  • Experimental: Substudy 2 (Dose-Level 2): Derazantinib 300 mg once daily + atezolizumab 1200 mg
    Patients with any solid tumors were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
  • Experimental: Substudy 3: Derazantinib 200 mg twice daily + atezolizumab 1200 mg
    Patients with urothelial cancer were treated with derazantinib 200 mg twice daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
  • Experimental: Substudy 4 (Cohort 4a):Derazantinib 300 mg once daily
    Patients with FGFR inhibitor resistant urothelial cancer were treated with derazantinib 300 mg once daily
  • Experimental: Substudy 4 (Cohort 4b):Derazantinib 300 mg once daily + atezolizumab 1200 mg
    Patients with urothelial cancer were treated with derazantinib 300 mg once daily in combination with atezolizumab 1200 mg given every 3 weeks as IV infusion
  • Experimental: Substudy 5: Derazantinib 200 mg twice daily
    Patients with urothelial cancer were treated with derazantinib 200 mg twice daily

Primary Outcome Measure

Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5) [ Time Frame: From first dose up to 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
CTCA Clinical Research Inc., AtlantaNewnanGeorgia30265-
Englander Institute Weill Cornell MedicineNew YorkNew York10021-
New York Cancer and Blood SpecialistsPort Jefferson StationNew York11776-
University of Texas Southwestern Medical Center (UTSWMC)DallasTexas75390-8852-
MD AndersonHoustonTexas77030-
NEXT OncologySan AntonioTexas78229-
Medical Oncology Associates PS (dba Summit Cancer Centers)SpokaneWashington99208-

Find similar trials in Newnan, GA

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By research site
CTCA Clinical Research Inc., Atlanta· Newnan, GAEnglander Institute Weill Cornell Medicine· New York, NYNew York Cancer and Blood Specialists· Port Jefferson Station, NYUniversity of Texas Southwestern Medical Center (UTSWMC)· Dallas, TXMD Anderson· Houston, TXNEXT Oncology· San Antonio, TX

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