Erdafitinib
Information
- Drug Name
- Erdafitinib
- Description
- Entry(CIViC)
- 6
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| transitional cell carcinoma | FGFR2 FGFR2-BICC1 | C |
Predictive
|
Supports
|
Sensitivity/Response |
N/A
|
3 | 26324363 | Detail |
| cancer | FGFR2 FUSION FGFR2 FUSION | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26324363 | Detail |
| cancer | FGFR3 FGFR3-TACC3 | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26324363 | Detail |
| endometrial cancer | FGFR2 FGFR2-BICC1 | C |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26324363 | Detail |
| adrenal carcinoma | FGFR3 K650E FGFR3 K650E | C |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 26324363 | Detail |
| transitional cell carcinoma | FGFR3 MUTATION FGFR3 MUTATION | A |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 31340094 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| Phase 1 study of pan-FGFR inhibitor JNJ-42756493 i... | FGFR2 | FGFR2 FGFR2-BICC1 | Sensitivity | true | CIViC Evidence | detail |
| Phase 1 study of pan-FGFR inhibitor JNJ-42756493 i... | FGFR2 | FGFR2 FUSION FGFR2 FUSION | Sensitivity | true | CIViC Evidence | detail |
| Phase 1 study of pan-FGFR inhibitor JNJ-42756493 i... | FGFR3 | FGFR3 FGFR3-TACC3 | Sensitivity | true | CIViC Evidence | detail |
| Phase 1 study of pan-FGFR inhibitor JNJ-42756493 i... | FGFR2 | FGFR2 FGFR2-BICC1 | Sensitivity | true | CIViC Evidence | detail |
| Phase 1 study of pan-FGFR inhibitor JNJ-42756493 i... | FGFR3 | FGFR3 K650E FGFR3 K650E | Sensitivity | true | CIViC Evidence | detail |
| In a phase 2 trial, patients with locally advanced... | FGFR3 | FGFR3 MUTATION FGFR3 MUTATION | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT02365597 | Active, not recruiting | Phase 2 | An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer | April 22, 2015 | December 31, 2024 |
| NCT02465060 | Active, not recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | August 17, 2015 | December 31, 2025 |
| NCT03210714 | Active, not recruiting | Phase 2 | Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial) | June 5, 2018 | October 1, 2024 |
| NCT03238196 | Active, not recruiting | Phase 1 | Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer | August 18, 2017 | September 25, 2024 |
| NCT03390504 | Active, not recruiting | Phase 3 | A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations | March 23, 2018 | November 1, 2026 |
| NCT03473743 | Active, not recruiting | Phase 1/Phase 2 | A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer | April 5, 2018 | June 30, 2025 |
| NCT04083976 | Active, not recruiting | Phase 2 | A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations | November 20, 2019 | September 20, 2024 |
| NCT04172675 | Active, not recruiting | Phase 2 | A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) | February 28, 2020 | March 1, 2025 |
| NCT04754425 | Active, not recruiting | Phase 2 | Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer | July 15, 2021 | June 30, 2026 |
| NCT06308822 | Active, not recruiting | Phase 2 | Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) | August 20, 2018 | December 31, 2025 |
| NCT06351371 | Active, not recruiting | Phase 2 | Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2) | July 3, 2018 | December 31, 2025 |
| NCT03825484 | Approved for marketing | Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options | |||
| NCT03547037 | Completed | Phase 1 | A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers | August 31, 2018 | July 4, 2022 |
| NCT04330248 | Completed | Phase 1 | A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants | March 31, 2020 | June 14, 2022 |
| NCT02699606 | Completed | Phase 2 | A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma | July 8, 2016 | March 15, 2024 |
| NCT03066687 | Completed | Phase 1 | A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants | March 14, 2017 | May 12, 2017 |
| NCT03135106 | Completed | Phase 1 | A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants | April 14, 2017 | September 1, 2017 |
| NCT06328491 | Completed | N/A | Erdafitinib in Metastatic Steroid-cell Ovarian Cancer | May 30, 2022 | August 22, 2022 |
| NCT06204614 | Not yet recruiting | Early Phase 1 | Drug Screening Using IMD in Bladder Cancer | February 14, 2024 | July 1, 2025 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT04917809 | Recruiting | Phase 2 | A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer | February 17, 2022 | August 2025 |
| NCT04963153 | Recruiting | Phase 1 | Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy | July 7, 2022 | September 1, 2024 |
| NCT03155620 | Recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | July 31, 2017 | September 30, 2027 |
| NCT05859334 | Recruiting | Phase 2 | Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment | January 4, 2024 | October 23, 2026 |
| NCT03827850 | Terminated | Phase 2 | FGFR Inhibitor in FGFR Dysregulated Cancer | March 25, 2019 | October 14, 2022 |
| NCT03999515 | Terminated | Phase 2 | Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer | April 27, 2020 | June 6, 2021 |
| NCT03587363 | Terminated | Phase 1 | A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib | December 6, 2018 | December 22, 2020 |
| NCT05564416 | Withdrawn | Phase 2 | Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial | October 12, 2023 | November 3, 2023 |