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Completed

NCT Number: NCT04045613

Derazantinib and Atezolizumab in Patients With Urothelial Cancer

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.

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Key information

Conditions

Urothelial Carcinoma Acrocephalosyndactylia Bone Diseases Bone Diseases, Developmental Carcinoma Carcinoma, Transitional Cell Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Limb Deformities, Congenital Male Urogenital Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Syndactyly Synostosis Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Coastal Cancer Care, Birtinya, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Objective Response Rate (ORR) Based on RECIST 1.1 (Substudies 1,3,4 and 5)

    Time frame: From first dose up to 2 years

    ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1

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

    Time frame: From first dose up to 2 years

    The RP2D was determined by a joint decision taken by the Independent Data Monitoring Committee (IDMC), Investigators, and the Sponsor in reviewing the aggregate of DLT and AE data, and considering efficacy data

  3. Number of Patients With Dose-limiting Toxicities (DLTs) in Substudy 2

    Time frame: From first dose up to 2 years

    In Substudy 2, the primary endpoint was the number of patients with DLTs. A DLT was defined as a clinically-significant adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications. Any DLT had to be a toxicity considered at least possibly related to derazantinib or the combination of derazantinib and atezolizumab

Secondary outcomes

  1. Disease Control Rate (DCR) Per RECIST 1.1 in All Substudies

    Time frame: From first dose up to 2 years

    DCR was defined as the proportion of patients who achieved a confirmed clinical response (CR), partial response (PR) or stable disease (SD) by BICR using the internationally recognized criteria in accordance with RECIST Version 1.1

  2. Duration of Response (DOR) Per RECIST 1.1

    Time frame: From first dose up to 2 years

    DOR was calculated from the first date of documented tumor response (confirmed CR or PR) to the date of disease progression as assessed by BICR or death per RECIST 1.1

  3. ORR Based on RECIST 1.1 (Substudy 2)

    Time frame: From first dose up to 2 years

    ORR was defined as the proportion of patients who achieved a confirmed clinical response (CR) or partial response (PR) by blinded investigator central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST) Version 1.1

  4. Progression-free Survival (PFS) by RECIST in All Substudies

    Time frame: From first dose up to 2 years

    PFS was calculated as the time from cohort assignment until disease progression as assessed by BICR, or death from any cause, whichever came first

  5. Overall Survival (OS) in All Substudies

    Time frame: From first dose up to 2 years

    OS was calculated from the date of cohort assignment until death from any cause

  6. Number of Patients With at Least Grade 3 Adverse Events (AEs)

    Time frame: From first dose and until 90 days following the last dose

    Common Terminology Criteria for Adverse Events (CTCAE) displayed by increasing severity grades 3 to 5 (CTCAE grade 3/4/5 )

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study title

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

Acronym: FIDES-02

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2019
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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