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Trial record 1 of 1 for:    DZB-CS-201
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Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02)

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ClinicalTrials.gov Identifier: NCT04045613
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica

Brief Summary:
The purpose of this study is to evaluate efficacy of derazantinib single-agent 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 Drug: Atezolizumab (drug supplied by Hoffmann-La Roche) Phase 1 Phase 2

Detailed Description:
The study comprises four open-label substudies in patients with advanced urothelial cancer harboring FGFR GA who will be treated by single-agent derazantinib 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 303 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
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Derazantinib [Substudy 1]
Patients with urothelial cancer who have progressed on at least one line of standard treatment will be treated with derazantinib.
Drug: Derazantinib

Substudy 1: Derazantinib will be administered orally at a dose of 300mg once per day

Substudy 2: Derazantinib will be administered orally at various dose levels

Substudy 3 and 4: Derazantinib will be administered orally at the dose of 300mg once per day as single agent or at the identified RP2D for derazantinib-atezolizumab


Experimental: Derazantinib + Atezolizumab: Dose finding [Substudy 2]
Dose finding and dose expansion in patients with solid tumor.
Drug: Derazantinib

Substudy 1: Derazantinib will be administered orally at a dose of 300mg once per day

Substudy 2: Derazantinib will be administered orally at various dose levels

Substudy 3 and 4: Derazantinib will be administered orally at the dose of 300mg once per day as single agent or at the identified RP2D for derazantinib-atezolizumab


Drug: Atezolizumab (drug supplied by Hoffmann-La Roche)
Atezolizumab will be intravenously administered every 3 weeks at a dose of 1200mg.

Experimental: Derazantinib +/- Atezolizumab: First line [Substudy 3]
Patients with urothelial cancer will be randomized for first-line treatment with either derazantinib alone or the recommended phase 2 dose (RP2D) for derazantinib-atezolizumab.
Drug: Derazantinib

Substudy 1: Derazantinib will be administered orally at a dose of 300mg once per day

Substudy 2: Derazantinib will be administered orally at various dose levels

Substudy 3 and 4: Derazantinib will be administered orally at the dose of 300mg once per day as single agent or at the identified RP2D for derazantinib-atezolizumab


Drug: Atezolizumab (drug supplied by Hoffmann-La Roche)
Atezolizumab will be intravenously administered every 3 weeks at a dose of 1200mg.

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 the RP2D for derazantinib-atezolizumab.
Drug: Derazantinib

Substudy 1: Derazantinib will be administered orally at a dose of 300mg once per day

Substudy 2: Derazantinib will be administered orally at various dose levels

Substudy 3 and 4: Derazantinib will be administered orally at the dose of 300mg once per day as single agent or at the identified RP2D for derazantinib-atezolizumab


Drug: Atezolizumab (drug supplied by Hoffmann-La Roche)
Atezolizumab will be intravenously administered every 3 weeks at a dose of 1200mg.




Primary Outcome Measures :
  1. Overall Response Rate (ORR) based on RECIST 1.1 [ Time Frame: Approximately up to 2 years ]
  2. Recommended Phase 2 dose (RP2D) of derazantinib in combination with atezolizumab [ Time Frame: Approximately up to 8 weeks ]

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 ]


Information from the National Library of Medicine

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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 FGFR genetic alteration
  • 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 corneal or retinal disorder
  • Phosphatemia greater than institutional upper limit of normal (ULN) at screening
  • Uncontrolled tumor-related hypercalcemia

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


Contacts
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Contact: Frédérique Cantero, MD +41 76 830 2499 frederique.cantero@basilea.com
Contact: Stephan Braun, MD +41 79 121 1561 stephan.braun@basilea.com

Locations
Show Show 39 study locations
Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
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Study Director: Frédérique Cantero, MD Basilea Pharmaceutica International Ltd
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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: July 10, 2020
Last Verified: July 2020
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
Antineoplastic Agents