7 completed, 5 terminated, 2 recruiting, 2 withdrawn. 18 Phase 2, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 18 | Completed 7, Terminated 5, Recruiting 2, Withdrawn 2, Active not recruiting 1, Unknown 1 |
| Phase 1 | 3 | Completed 1, Recruiting 1, Terminated 1 |
Follow Craniosynostoses: new trials by email Literature Review of Craniosynostoses trials Research Report on Craniosynostoses
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1 humanized monoclonal anti-FGFR1 antibody OM-RCA-01 - Renal Cell Carcinoma Metastatic, Prostate Cancer Metastatic | Phase 1 / Phase 2 | Recruiting | Kidney Cancer Research Bureau | 64 | 2025-12-02 | 2026-11-10 |
| Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration Pemigatinib - Non-Small Cell Lung Cancer (NSCLC) | Phase 2 | Completed | Incyte Corporation | 8 | 2022-04-29 | 2025-08-05 |
| NCCH2006/MK010 Trial (FORTUNE Trial) E7090 - Advanced or Recurrent Solid Tumors, FGFR Gene Alterations | Phase 2 | Recruiting | National Cancer Center, Japan | 75 | 2021-06-15 | 2025-10-03 |
| Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma Derazantinib, Derazantinib-paclitaxel-ramucirumab combination - Gastric Adenocarcinoma | Phase 1 / Phase 2 | Terminated | Basilea Pharmaceutica | 47 | 2020-10-06 | 2024-04-04 |
| Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205) Pemigatinib, Pembrolizumab, Gemcitabine - Metastatic Urothelial Carcinoma, Unresectable Urothelial Carcinoma | Phase 2 | Terminated | Incyte Corporation | 7 | 2020-05-14 | 2025-11-04 |
| Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations Infigratinib - Gastric Cancer, Gastroesophageal Junction Adenocarcinoma | Phase 2 | Unknown | LianBio LLC | 80 | 2020-05-13 | 2022-06-27 |
| A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion E7090 - Cholangiocarcinoma | Phase 2 | Completed | Eisai Co., Ltd. | 63 | 2020-01-22 | 2026-03-02 |
| Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety Rogaratinib (BAY1163877), Combination drug - Cancer | Phase 2 | Completed | Bayer | 1 | 2019-10-30 | 2022-04-01 |
| Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) Pemigatinib - Solid Tumor Malignancy | Phase 2 | Terminated | Incyte Corporation | 111 | 2019-10-17 | 2025-11-04 |
| Derazantinib and Atezolizumab in Patients With Urothelial Cancer Derazantinib 300 mg once daily monotherapy, Derazantinib 200 mg once daily + atezolizumab 1200 mg, Derazantinib 300 mg once daily+ atezolizumab 1200 mg - Urothelial Carcinoma | Phase 1 / Phase 2 | Completed | Basilea Pharmaceutica | 95 | 2019-08-02 | 2023-10-13 |
| Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC) Rogaratinib - Squamous-cell Non-small Cell Lung Cancer | Phase 2 | Terminated | Swiss Cancer Institute | 15 | 2019-07-25 | 2022-11-09 |
| Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling Lenvatinib - Cancer | Phase 2 | Withdrawn | Teresa Helsten, MD | 2018-07-01 | 2018-08-02 | |
| Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations Lucitanib - Advanced Cancer | Phase 2 | Withdrawn | Teresa Helsten, MD | 2017-04-01 | 2018-08-02 | |
| Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202) Pemigatinib - Cholangiocarcinoma | Phase 2 | Completed | Incyte Corporation | 147 | 2017-01-16 | 2025-08-14 |
| A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) pemigatinib - UC (Urothelial Cancer) | Phase 2 | Completed | Incyte Corporation | 263 | 2017-01-12 | 2025-08-14 |
| 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 Erdafitinib - Neoplasm | Phase 2 | Completed | Janssen Research & Development, LLC | 35 | 2016-07-08 | 2025-04-27 |
| Efficacy of Amicar for Children Having Craniofacial Surgery Amicar (ε-aminocaproic acid), normal saline - Craniosynostosis | Phase 2 | Active not recruiting | Children's National Research Institute | 22 | 2014-10-01 | 2026-04-07 |
| Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF Brivanib, Irinotecan - Colorectal Cancer, Colorectal Adenocarcinoma | Phase 2 | Terminated | M.D. Anderson Cancer Center | 8 | 2011-08-01 | 2020-09-03 |
Acrocephalosyndactylia (17) · Carcinoma, Transitional Cell (4) · Neoplasms (4) · Carcinoma, Non-Small-Cell Lung (3) · Cholangiocarcinoma (3) · Breast Neoplasms (2) · Head and Neck Neoplasms (2) · Neoplasm Metastasis (2) · Stomach Neoplasms (2) · Colorectal Neoplasms (1) · Esophageal Neoplasms (1) · Kidney Neoplasms (1) · Lung Neoplasms (1) · Prostatic Neoplasms (1)
Bone Diseases (18) · Bone Diseases, Developmental (18) · Congenital Abnormalities (18) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (18) · Craniofacial Abnormalities (18) · Dysostoses (18) · Musculoskeletal Abnormalities (18) · Musculoskeletal Diseases (18) · Synostosis (18) · Limb Deformities, Congenital (17) · Syndactyly (17) · Neoplasms (10) · Neoplasms by Site (8) · Carcinoma (7)
pemigatinib (5) · Rogaratinib (2) · derazantinib (2) · Aminocaproic Acid (1) · Carboplatin (1) · Drug Combinations (1) · E-3810 (1) · Gemcitabine (1) · INCB 54828-101 (1) · Irinotecan (1) · Rabeprazole (1) · Saline Solution (1) · atezolizumab (1) · brivanib (1) · erdafitinib (1)
Incyte Corporation (5) · Basilea Pharmaceutica (2) · Teresa Helsten, MD (2) · Bayer (1) · Children's National Research Institute (1) · Eisai Co., Ltd. (1) · Janssen Research & Development, LLC (1) · Kidney Cancer Research Bureau (1) · LianBio LLC (1) · M.D. Anderson Cancer Center (1) · National Cancer Center, Japan (1) · Swiss Cancer Institute (1)
United States (11) · France (7) · Germany (7) · Italy (7) · Spain (7) · Japan (6) · United Kingdom (6) · South Korea (5) · Belgium (4) · Switzerland (4) · China (3) · Israel (3) · Poland (3) · Australia (2) · Austria (2)
Teresa Helsten, MD (2) · Alfredo Addeo, MD (1) · Ekaterine Asatiani, MD (1) · Luis Feliz Vinas, MD (1) · Luisa Veronese, MD (1) · Michael Overman, MD (1) · Peter Langmuir, MD (1) · Qiao Sun, Doctor (1) · Srijaya K Reddy, MD, MBA (1)
PMID 32203698, PMID 35544727, PMID 35945547, PMID 36206041, PMID 37956738, PMID 38039831, PMID 38627238, PMID 38710951, PMID 39138436, PMID 42337043
2019 (3), 2016 (2), 2018 (1)