Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bayer
Study ID
NCT03473756
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rogaratinib (BAY1163877) — DRUG
    Part A:Rogaratinib will be administered orally until disease progression, unacceptable toxicity or consent withdrawal. The starting dose of 800 mg b.i.d. will be confirmed using a dose selection design.
  • Atezolizumab — DRUG
    Part A: A fixed dose of 1200 mg atezolizumab will be administered through intravenous (i.v.) infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity or consent withdrawal.

Study Details

FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment. The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients. The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma. Of note, patients who participate in Part A are not allowed to participate in Part B. Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development. Part B of the study will no longer be conducted.

Key Dates

Start date
May 15, 2018
Status verified
Mar 2025
Primary completion
Jul 16, 2021
Completion
Jul 10, 2024

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rogaratinib + Atezolizumab in Part A
    Part A: Part A is conducted in patients who are cisplatin-ineligible and have had no prior systemic treatment for locally advanced or metastatic disease. Patients will receive rogaratinib plus atezolizumab combination treatment.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicities(DLTs) [ Time Frame: Up to 21 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-
UChicago Medicine Comprehensive Cancer Center - Hyde ParkChicagoIllinois60637-
Barbara Ann Karmanos Cancer Institute - Detroit HeadquartersDetroitMichigan48201-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

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