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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 : Completed
First Posted : August 5, 2019
Last Update Posted : October 20, 2022
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Derazantinib dose level 1 (300mg once daily) monotherapy Drug: Derazantinib various dose levels in combination with atezolizumab Drug: Derazantinib dose level 2 (200 mg twice daily) monotherapy Drug: Derazantinib dose level 1 in combination with atezolizumab Drug: Derazantinib dose level 2 in combination with atezolizumab Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations
Actual Study Start Date : July 25, 2019
Actual Primary Completion Date : September 29, 2022
Actual Study Completion Date : September 29, 2022

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Derazantinib dose level 1 (300mg once daily) monotherapy
Derazantinib will be administered orally at a dose of 300 mg once per day.
Experimental: Derazantinib + atezolizumab: Dose finding [Substudy 2]
Dose finding and dose expansion in patients with solid tumor.
 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.
Experimental: Derazantinib + atezolizumab: First line [Substudy 3]
Patients with urothelial cancer will be treated with a combination of derazantinib and atezolizumab.
 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.
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.
 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 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.
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.
 Drug: Derazantinib dose level 2 (200 mg twice daily) monotherapy
Derazantinib will be administered orally at a dose of 200 mg twice daily.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) based on RECIST 1.1 [ Time Frame: Approximately up to 2 years ]
  2. 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 ]
  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 ]

Secondary Outcome Measures :
  1. Disease control rate per RECIST 1.1 [ Time Frame: Approximately up to 2 years ]
  2. Duration of Response per RECIST 1.1 [ Time Frame: Approximately up to 2 years ]
  3. Median progression-free survival (PFS) and PFS at 6 months [ Time Frame: Approximately up to 2 years ]
  4. Median overall survival (OS) and OS at 6 months [ Time Frame: Approximately up to 2 years ]
  5. Safety and tolerability of study treatment based on incidence of treatment-emergent adverse events [ Time Frame: Approximately up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045613


Locations
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Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
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Study Director: Manuel Häckl, MD Basilea Pharmaceutica International Ltd
More Information
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Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT04045613    
Other Study ID Numbers: DZB-CS-201
2019-000359-15 ( EudraCT Number )
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: October 20, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Basilea Pharmaceutica:
metastatic urothelial cancer
bladder cancer
Fibroblast Growth Factor Receptor
FGFR genetic aberration
targeted therapy
derazantinib
 checkpoint inhibitor
immune checkpoint blockade
atezolizumab
Tecentriq
solid tumor
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Atezolizumab
Antibodies, Monoclonal
 Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs