Trial · NCT03410693

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

NCT03410693, Phase 2, Phase 3, Completed, Bayer; results first posted 2021-12-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma. Trials, record NCT03410693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03410693

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
NCT number: NCT03410693
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 175 participants, actual
Lead sponsor: Bayer
Conditions: Carcinoma, Transitional Cell
Interventions: Rogaratinib (BAY1163877), Chemotherapy
First posted: 2018-01-25
Last updated: 2022-09-28
Other registries' IDs: eudract:2016-004340-11
Results first posted: 2021-12-29

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate (ORR) - Central Assessment	From start of treatment up to end of active follow-up, approximately 29 months	ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.
Secondary	Disease-control Rate (DCR) - Central Assessment	From start of treatment till end of active follow-up, approximately 29 months	DCR was defined as the percentage of participants whose overall best response was not a progressive disease (i.e., CR, PR, stable disease \[SD\] or Non CR/Non PD).
Secondary	Progression-free Survival (PFS) - Central Assessment	From start of treatment till end of active follow-up, approximately 29 months	Progression free survival (PFS) was defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment or both) or death due to any cause (if death occurred before progression was documented).
Secondary	Duration of Response (DOR) - Central Assessment	From start of treatment till end of active follow-up, approximately 29 months	DOR (for patients with PR and CR only) was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression (including symptomatic deterioration) or death, whichever was earlier
Secondary	Number of Participants With Treatment Emergent Adverse Events	From start of treatment up to 30 days after the last administration of study treatment, approximately 29 months	A treatment-emergent event was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Objective Response Rate (ORR) - Central Assessment	From start of treatment up to end of active follow-up, approximately 29 months	percentage of participants	NUMBER
SECONDARY	Disease-control Rate (DCR) - Central Assessment	From start of treatment till end of active follow-up, approximately 29 months	percentage of participants	NUMBER
SECONDARY	Progression-free Survival (PFS) - Central Assessment	From start of treatment till end of active follow-up, approximately 29 months	months	MEDIAN
SECONDARY	Duration of Response (DOR) - Central Assessment	From start of treatment till end of active follow-up, approximately 29 months	months	MEDIAN
SECONDARY	Number of Participants With Treatment Emergent Adverse Events	From start of treatment up to 30 days after the last administration of study treatment, approximately 29 months	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Objective Response Rate (ORR) - Central Assessment	Rogaratinib (BAY1163877)_Overall Population	19.5	95% Confidence Interval 11.8 to 29.4	percentage of participants
Objective Response Rate (ORR) - Central Assessment	Chemotherapy_Overall Population	21.6	95% Confidence Interval 13.5 to 31.6	percentage of participants
Objective Response Rate (ORR) - Central Assessment	Rogaratinib_WT Population	19.4	95% Confidence Interval 10.4 to 31.4	percentage of participants
Objective Response Rate (ORR) - Central Assessment	Chemotherapy_WT Population	23.8	95% Confidence Interval 14.0 to 36.2	percentage of participants
Disease-control Rate (DCR) - Central Assessment	Rogaratinib (BAY1163877)_Overall Population	50.6	95% Confidence Interval 39.6 to 61.5	percentage of participants
Disease-control Rate (DCR) - Central Assessment	Chemotherapy_Overall Population	55.7	95% Confidence Interval 44.7 to 66.3	percentage of participants
Disease-control Rate (DCR) - Central Assessment	Rogaratinib_WT Population	53.2	95% Confidence Interval 40.1 to 66.0	percentage of participants
Disease-control Rate (DCR) - Central Assessment	Chemotherapy_WT Population	63.5	95% Confidence Interval 50.4 to 75.3	percentage of participants
Progression-free Survival (PFS) - Central Assessment	Rogaratinib (BAY1163877)_Overall Population	2.7	95% Confidence Interval 1.6 to 4.6	months
Progression-free Survival (PFS) - Central Assessment	Chemotherapy_Overall Population	3.2	95% Confidence Interval 2.7 to 4.4	months

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rogaratinib (BAY1163877)_Overall Population	87
Overall Study	STARTED	Chemotherapy_Overall Population	88
Overall Study	Started Treatment	Rogaratinib (BAY1163877)_Overall Population	86
Overall Study	Started Treatment	Chemotherapy_Overall Population	82
Overall Study	Active Follow-up Performed	Rogaratinib (BAY1163877)_Overall Population	61
Overall Study	Active Follow-up Performed	Chemotherapy_Overall Population	56
Overall Study	Entered Long Term Follow-up	Rogaratinib (BAY1163877)_Overall Population	56
Overall Study	Entered Long Term Follow-up	Chemotherapy_Overall Population	69
Overall Study	COMPLETED	Rogaratinib (BAY1163877)_Overall Population	0
Overall Study	COMPLETED	Chemotherapy_Overall Population	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events272

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Rogaratinib (BAY1163877)	11	86	17
other	Anaemia	Blood and lymphatic system disorders	Chemotherapy	28	82	66
other	Neutropenia	Blood and lymphatic system disorders	Rogaratinib (BAY1163877)	3	86	6
other	Neutropenia	Blood and lymphatic system disorders	Chemotherapy	19	82	30
other	Dry eye	Eye disorders	Rogaratinib (BAY1163877)	5	86	5
other	Dry eye	Eye disorders	Chemotherapy	3	82	3
other	Detachment of retinal pigment epithelium	Eye disorders	Rogaratinib (BAY1163877)	7	86	16
other	Detachment of retinal pigment epithelium	Eye disorders	Chemotherapy	0	82	0
other	Subretinal fluid	Eye disorders	Rogaratinib (BAY1163877)	7	86	8
other	Subretinal fluid	Eye disorders	Chemotherapy	0	82	0

1 to 10 of 272Source ClinicalTrials.gov

See all 272 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rogaratinib (BAY1163877)	47	86
Total, all-cause mortality	Chemotherapy	45	82
Total, other adverse events	Rogaratinib (BAY1163877)	85	86
Total, other adverse events	Chemotherapy	77	82
Total, serious adverse events	Rogaratinib (BAY1163877)	39	86
Total, serious adverse events	Chemotherapy	33	82

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30807645	DERIVED	PubMed
36240478	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Rogaratinib (BAY1163877) vs Chemotherapy: deaths from any cause	Trial comparisons
Rogaratinib (BAY1163877) vs Chemotherapy: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03410693

GET https://conductscience.org/api/trials/v1/NCT03410693/events?page=2

API reference For AI assistants