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Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045613
Recruitment Status : Active, not recruiting
First Posted : August 5, 2019
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

Tracking Information
First Submitted Date  ICMJE July 26, 2019
First Posted Date  ICMJE August 5, 2019
Last Update Posted Date August 9, 2022
Actual Study Start Date  ICMJE July 25, 2019
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
  • Overall Response Rate (ORR) based on RECIST 1.1 [ Time Frame: Approximately up to 2 years ]
  • Safety and tolerability of derazantinib 200 mg twice a day with atezolizumab 1200 mg every three weeks [ Time Frame: After enrollment of the first 10 patients in substudy 3 ]
  • Safety and tolerability of derazantinib 200 mg twice a day as monotherapy [ Time Frame: After enrollment of the first 10 patients in substudy 5 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
  • Overall Response Rate (ORR) based on RECIST 1.1 [ Time Frame: Approximately up to 2 years ]
  • Recommended Phase 2 dose (RP2D) of derazantinib in combination with atezolizumab [ Time Frame: Approximately up to 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
  • Disease control rate per RECIST 1.1 [ Time Frame: Approximately up to 2 years ]
  • Duration of Response per RECIST 1.1 [ Time Frame: Approximately up to 2 years ]
  • Median progression-free survival (PFS) and PFS at 6 months [ Time Frame: Approximately up to 2 years ]
  • Median overall survival (OS) and OS at 6 months [ Time Frame: Approximately up to 2 years ]
  • Safety and tolerability of study treatment based on incidence of treatment-emergent adverse events [ Time Frame: Approximately up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Official Title  ICMJE An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations
Brief Summary The purpose of this study is 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.
Detailed Description The study comprises five open-label substudies in patients with advanced urothelial cancer harboring FGFR GA who will be treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolls patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urothelial Carcinoma
Intervention  ICMJE
  • Drug: Derazantinib dose level 1 (300mg once daily) monotherapy
    Derazantinib will be administered orally at a dose of 300 mg once per day.
  • Drug: Derazantinib various dose levels in combination with atezolizumab
    Derazantinib was administered orally at various dose levels and the RP2D of derazantinib in combination with atezolizumab was determined to be 300 mg once per day derazantinib plus 1200 mg atezolizumab every three weeks.
  • Drug: Derazantinib dose level 2 (200 mg twice daily) monotherapy
    Derazantinib will be administered orally at a dose of 200 mg twice daily.
  • Drug: Derazantinib dose level 1 in combination with atezolizumab
    Derazantinib will be administered orally at a dose of 300 mg once per day in combination with atezolizumab 1200 mg every three weeks.
  • Drug: Derazantinib dose level 2 in combination with atezolizumab
    Derazantinib will be administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every three weeks.
Study Arms  ICMJE
  • Experimental: Derazantinib monotherapy [Substudy 1]
    Patients with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib dose level 1.
    Intervention: Drug: Derazantinib dose level 1 (300mg once daily) monotherapy
  • Experimental: Derazantinib + atezolizumab: Dose finding [Substudy 2]
    Dose finding and dose expansion in patients with solid tumor.
    Intervention: Drug: Derazantinib various dose levels in combination with atezolizumab
  • Experimental: Derazantinib + atezolizumab: First line [Substudy 3]
    Patients with urothelial cancer will be treated with a combination of derazantinib and atezolizumab.
    Intervention: Drug: Derazantinib dose level 2 in combination with atezolizumab
  • Experimental: Derazantinib +/- atezolizumab: Second line [Substudy 4]
    Patients with urothelial cancer progressing after prior FGFR inhibitor treatment will be randomized to receive either derazantinib alone or a combination of derazantinib and atezolizumab.
    Interventions:
    • Drug: Derazantinib dose level 1 (300mg once daily) monotherapy
    • Drug: Derazantinib dose level 1 in combination with atezolizumab
  • Experimental: Derazantinib monotherapy [Substudy 5]
    Patients with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib dose level 2.
    Intervention: Drug: Derazantinib dose level 2 (200 mg twice daily) monotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 8, 2022)
95
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2019)
303
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract
  • Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or progressing disease
  • Documented central FGFR genetic aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions)
  • Measurable disease per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Receipt of chemotherapy, targeted therapies, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug whichever is longer before the first dose of study drug.
  • Concurrent evidence of any clinically significant corneal or retinal disorder
  • Phosphatemia greater than institutional upper limit of normal (ULN) at screening
  • Uncontrolled tumor-related hypercalcemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Czechia,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT04045613
Other Study ID Numbers  ICMJE DZB-CS-201
2019-000359-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Basilea Pharmaceutica
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Basilea Pharmaceutica
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Manuel Häckl, MD Basilea Pharmaceutica International Ltd
PRS Account Basilea Pharmaceutica
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP