Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma (FORT-2)
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|ClinicalTrials.gov Identifier: NCT03473756|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2018
Last Update Posted : November 23, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Drug: Rogaratinib (BAY1163877) Drug: Atezolizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Part A is open-label.|
|Official Title:||An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma|
|Actual Study Start Date :||May 15, 2018|
|Actual Primary Completion Date :||July 16, 2021|
|Estimated Study Completion Date :||December 22, 2023|
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.
Drug: Rogaratinib (BAY1163877)
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.
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.
- Number of subjects with Dose-limiting toxicities(DLTs) in Part A [ Time Frame: Up to 21 days ]A DLT is defined as any of the hematological, non-hematological or other TEAEs occurring during Cycle 1 and regarded by the investigators and/or sponsor to be related to rogaratinib or atezolizumab. The CTCAE v 4.03 will be used to assess toxicities / adverse events.
- Number of subjects with treatment-emergent adverse events (TEAEs) in Part A [ Time Frame: Up to 5 months ]Part A
- Number of subjects with drug-related TEAEs in Part A [ Time Frame: Up to 5 months ]Part A
- Number of subjects with treatment-emergent serious adverse events(TESAEs) in Part A [ Time Frame: Up to 5 months ]Part A
- Objective Response Rate(ORR) in Part A [ Time Frame: Up to 5 months ]
Part A:Objective response rate (ORR) is defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom best overall tumor response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.
For all patients, the best overall tumor response will be determined locally by investigators using the RECIST criteria (v1.1).
- Maximal plasma concentration (Cmax) of rogaratinib in Part A [ Time Frame: At cycle 1 Day 1 ]Part A
- Area under the curve(0-8) (AUC(0-8)) of rogaratinib in Part A [ Time Frame: At cycle 1 Day 1 ]Part A
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): NCT03473756