Number of Participants With Dose-limiting Toxicities(DLTs)
Primary
· Up to 21 days
| Group | Value | 95% CI |
|---|---|---|
| Rogaratinib 800 mg BID + Atezolizumab | 1 | |
| Rogaratinib 600 mg BID + Atezolizumab | 4 |
Last reviewed · How we verify
NCT03473756: FORT-2
Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma
Completed
Phase 1
Results posted
Last updated 9 April 2025
What this trial tests
Phase 1 trial testing Rogaratinib (BAY1163877) in Urothelial Carcinoma in 37 participants. Completed in 10 July 2024.
Timeline
15 May 2018
Primary endpoint
16 July 2021
16 July 2021
10 July 2024
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 15 May 2018 |
| Primary completion | 16 July 2021 |
| Estimated completion | 10 July 2024 |
| Sites | 30 locations across France, Italy, Japan, Austria, Germany, South Korea, United States, Spain |
Drugs / interventions tested
- Rogaratinib (BAY1163877) — full drug profile →
- Atezolizumab (atezolizumab) — full drug profile →
Conditions studied
- Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Primary
· up to 90 days after the last study medication intake, an average of 60 days
| Group | Value | 95% CI |
|---|---|---|
| Rogaratinib 800 mg BID + Atezolizumab | 11 | |
| Rogaratinib 600 mg BID + Atezolizumab | 26 |
Number of Participants With Drug-related TEAEs
Primary
· up to 90 days after the last study medication intake, an average of 60 days
| Group | Value | 95% CI |
|---|---|---|
| Rogaratinib 800 mg BID + Atezolizumab | 11 | |
| Rogaratinib 600 mg BID + Atezolizumab | 26 |
Number of Participants With Treatment-emergent Serious Adverse Events(TESAEs)
Primary
· up to 90 days after the last study medication intake, an average of 60 days
| Group | Value | 95% CI |
|---|---|---|
| Rogaratinib 800 mg BID + Atezolizumab | 8 | |
| Rogaratinib 600 mg BID + Atezolizumab | 14 |
Objective Response Rate(ORR)
Secondary
· Up to 5 months
Objective response rate (ORR) was defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom best overall tumor response was not CR or PR, as well as patients without any post-baseline tumor assessment were considered non-responders. For all patients, the best overall tumor response was determined locally by investigators using the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance o
| Group | Value | 95% CI |
|---|---|---|
| Rogaratinib 800 mg BID + Atezolizumab | 1 | |
| Rogaratinib 600 mg BID + Atezolizumab | 4 | |
| Rogaratinib 800 mg BID + Atezolizumab | 1 | |
| Rogaratinib 600 mg BID + Atezolizumab | 10 | |
| Rogaratinib 800 mg BID + Atezolizumab | 9 | |
| Rogaratinib 600 mg BID + Atezolizumab | 12 |
Maximal Plasma Concentration (Cmax) of Rogaratinib
Secondary
· At cycle 1 Day 1
| Group | Value | 95% CI |
|---|---|---|
| Rogaratinib 800 mg BID + Atezolizumab | 13207.846 | ± 1.379 |
| Rogaratinib 600 mg BID + Atezolizumab | 10372.864 | ± 1.404 |
Area Under the Rogaratinib Concentration Versus Time Curve (AUC)
Secondary
· At cycle 1 Day 1, 0-t(last)
| Group | Value | 95% CI |
|---|---|---|
| Rogaratinib 800 mg BID + Atezolizumab | 59187.389 | ± 1.513 |
| Rogaratinib 600 mg BID + Atezolizumab | 45768.289 | ± 1.449 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events (TEAEs) were defined as any event arising or worsening after the start of study drug administration up to 90 days after the last study medication intake, an average of 60 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rogaratinib 800 mg BID + Atezolizumab
Serious: 8/11 (73%)
Deaths: 9/11
Rogaratinib 600 mg BID + Atezolizumab
Serious: 14/26 (54%)
Deaths: 11/26
Serious adverse events (38 terms)
| Reaction | System | Rogaratinib 800 mg BID + A… | Rogaratinib 600 mg BID + A… |
|---|---|---|---|
| Angina unstable | Cardiac disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Supraventricular tachycardia | Cardiac disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Gastrointestinal vascular malformation haemorrhagic | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| General physical health deterioration | General disorders | — | — |
| Hepatitis | Hepatobiliary disorders | — | — |
| Hepatotoxicity | Hepatobiliary disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Pyelonephritis | Infections and infestations | — | — |
| Respiratory tract infection | Infections and infestations | — | — |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | — | — |
| Post procedural haematoma | Injury, poisoning and procedural complications | — | — |
| Craniocerebral injury | Injury, poisoning and procedural complications | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Renal function test abnormal | Investigations | — | — |
Other adverse events (244 terms — click to expand)
| Reaction | System | Rogaratinib 800 mg BID + A… | Rogaratinib 600 mg BID + A… |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — |
| Hyperphosphataemia | Metabolism and nutrition disorders | — | — |
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Asthenia | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Lipase increased | Investigations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Amylase increased | Investigations | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Vision blurred | Eye disorders | — | — |
| Serous retinopathy | Eye disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Oral candidiasis | Infections and infestations | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — | — |
| Onychomadesis | Skin and subcutaneous tissue disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Blood creatinine increased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Weight decreased | Investigations | — | — |
| Hypercalcaemia | Metabolism and nutrition disorders | — | — |
| Neck pain | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
Most-reported serious reactions: Angina unstable, Atrial fibrillation, Cardiac arrest, Supraventricular tachycardia, Constipation, Colitis, Abdominal pain, Diarrhoea haemorrhagic.
Data from ClinicalTrials.gov NCT03473756 adverse events section.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Fibroblast growth factor receptors in cancer: genetic alterations, diagnostics, therapeutic targets and mechanisms of resistance.
Krook MA, Reeser JW, Ernst G, Barker H, et al · · 2021 · cited 244× · PMID 33268819 · DOI 10.1038/s41416-020-01157-0 -
Unleashing the potential of combining FGFR inhibitor and immune checkpoint blockade for FGF/FGFR signaling in tumor microenvironment.
Ruan R, Li L, Li X, Huang C, et al · · 2023 · cited 86× · PMID 36966334 · DOI 10.1186/s12943-023-01761-7 -
Structure, activation and dysregulation of fibroblast growth factor receptor kinases: perspectives for clinical targeting.
Farrell B, Breeze AL. · · 2018 · cited 77× · PMID 30545934 · DOI 10.1042/bst20180004 -
Targeted therapies for advanced bladder cancer: new strategies with FGFR inhibitors.
Casadei C, Dizman N, Schepisi G, Cursano MC, et al · · 2019 · cited 76× · PMID 31803255 · DOI 10.1177/1758835919890285 -
Current Strategies and Novel Therapeutic Approaches for Metastatic Urothelial Carcinoma.
Mollica V, Rizzo A, Montironi R, Cheng L, et al · · 2020 · cited 75× · PMID 32498352 · DOI 10.3390/cancers12061449 -
Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models.
Grünewald S, Politz O, Bender S, Héroult M, et al · · 2019 · cited 73× · PMID 30807645 · DOI 10.1002/ijc.32224 -
Tyrosine Kinase Receptors in Oncology.
Esteban-Villarrubia J, Soto-Castillo JJ, Pozas J, San Román-Gil M, et al · · 2020 · cited 72× · PMID 33198314 · DOI 10.3390/ijms21228529 -
FGFR4: A promising therapeutic target for breast cancer and other solid tumors.
Levine KM, Ding K, Chen L, Oesterreich S. · · 2020 · cited 68× · PMID 32492514 · DOI 10.1016/j.pharmthera.2020.107590
Verify or expand the search:
- PubMed search for NCT03473756
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03473756 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 9 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03473756.
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