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Brief Title: Derazantinib and Atezolizumab in Patients With Urothelial Cancer

An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

INTRODUCTION

  • Org Study ID: DZB-CS-201
  • Secondary ID: N/A
  • NCT ID: NCT04045613
  • Sponsor: Basilea Pharmaceutica

BRIEF SUMMARY

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.

DETAILED DESCRIPTION

The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated by derazantinib monotherapy or derazantinib in combination with atezolizumab. The study enrolled patients with cisplatin-ineligible status, or patients whose disease progressed after either first-line treatment or prior treatment with FGFR inhibitors.

  • Overall Status
    Completed
  • Start Date
    August 2, 2019
  • Phase
    P, P
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)

Primary Outcome 1 - Timeframe: From first dose up to 2 years

Primary Outcome 2 - Measure: Recommended Phase 2 Dose (RP2D) of Derazantinib-atezolizumab in Combination Based on DLT Criteria, Safety and Efficacy Data (Substudy 2)

Primary Outcome 2 - Timeframe: From first dose up to 2 years

Primary Outcome 3 - Measure: Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2

Primary Outcome 3 - Timeframe: From first dose up to 2 years

CONDITION

  • U

ELIGIBILITY

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) (Note; Substudy 2 started with patients requiring an FGFR GA, but this requirement was removed from the protocol later on)

- * Measurable disease, as defined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

- * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2

- * Adequate organ functions as indicated by Screening visit local laboratory values
Exclusion Criteria:
* Receipt of prior cancer treatment within specific interval periods

- * Concurrent evidence of any clinically significant corneal or retinal disorder

- * History of clinically significant cardiac disorders

- * Known CNS metastases

- * Concurrent uncontrolled or active infection with human immunodeficiency virus

- * Active hepatitis B or chronic hepatitis B without current antiviral therapy

- * Active hepatitis C

- * Active tuberculosis

- * Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: M

Role: S

Affiliation: B

Overall Contact

Name: M

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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