Studies
| Study First Submitted Date | 2020-08-07 |
| Study First Posted Date | 2020-08-11 |
| Last Update Posted Date | 2023-04-27 |
| Verification Month Year | April 2023 |
| Verification Date | 2023-04-30 |
| Last Update Posted Date | 2023-04-27 |
Detailed Descriptions
| Sequence: | 20667084 |
| Description | This is an open-label study to provide expanded access to TAS-120 prior to its commercial availability for patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements who have failed standard therapy or who are unable to tolerate standard therapy. |
Facilities
| Sequence: | 199494157 | Sequence: | 199494158 | Sequence: | 199494159 | Sequence: | 199494160 | Sequence: | 199494161 | Sequence: | 199494162 | Sequence: | 199494163 | Sequence: | 199494164 | Sequence: | 199494165 | Sequence: | 199494166 | Sequence: | 199494167 | Sequence: | 199494168 | Sequence: | 199494169 | Sequence: | 199494170 | Sequence: | 199494171 | Sequence: | 199494172 | Sequence: | 199494173 |
| Name | Banner MD Anderson | Name | University of California, San Francisco (UCSF) | Name | UCLA Division of Hematology-Oncology | Name | Mount Sinai Center of Florida | Name | Advent Health Orlando | Name | University of Chicago | Name | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Name | Massachusetts General Hospital | Name | Dana Farber Cancer Institute | Name | University of Kansas Cancer Center | Name | Duke University Medical Center | Name | Providence Portland Medical Center | Name | MD Anderson | Name | Utah Cancer Specialists | Name | Seattle Cancer Care Alliance | Name | Aurora Cancer Care | Name | Aurora Research Institute |
| City | Gilbert | City | San Francisco | City | Santa Monica | City | Miami Beach | City | Orlando | City | Chicago | City | Baltimore | City | Boston | City | Boston | City | Lee’s Summit | City | Durham | City | Portland | City | Houston | City | Salt Lake City | City | Seattle | City | Grafton | City | Grafton |
| State | Arizona | State | California | State | California | State | Florida | State | Florida | State | Illinois | State | Maryland | State | Massachusetts | State | Massachusetts | State | Missouri | State | North Carolina | State | Oregon | State | Texas | State | Utah | State | Washington | State | Wisconsin | State | Wisconsin |
| Zip | 85234 | Zip | 94143 | Zip | 90404 | Zip | 33140 | Zip | 32804 | Zip | 60637 | Zip | 21231 | Zip | 02114 | Zip | 02215 | Zip | 64064 | Zip | 27710 | Zip | 97213 | Zip | 77030 | Zip | 84106 | Zip | 98109 | Zip | 53024 | Zip | 53024 |
| Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Browse Interventions
| Sequence: | 95770781 | Sequence: | 95770780 |
| Mesh Term | Antineoplastic Agents | Mesh Term | Futibatinib |
| Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | futibatinib |
| Mesh Type | mesh-ancestor | Mesh Type | mesh-list |
Conditions
| Sequence: | 52028911 |
| Name | Advanced Cholangiocarcinoma |
| Downcase Name | advanced cholangiocarcinoma |
Id Information
| Sequence: | 40046978 |
| Id Source | org_study_id |
| Id Value | TAS-120-401 |
Countries
| Sequence: | 42444350 |
| Name | United States |
| Removed | False |
Interventions
| Sequence: | 52341058 |
| Intervention Type | Drug |
| Name | TAS-120 |
| Description | Futibatinib 20mg QD orally on a 28 days cycle |
Keywords
| Sequence: | 79638776 |
| Name | Cholangiocarcinoma, CCA, FGFR2 Gene Rearrangements, TAS-120, Futibatinib |
| Downcase Name | cholangiocarcinoma, cca, fgfr2 gene rearrangements, tas-120, futibatinib |
Browse Conditions
| Sequence: | 192921420 | Sequence: | 192921421 | Sequence: | 192921422 | Sequence: | 192921423 | Sequence: | 192921424 | Sequence: | 192921425 |
| Mesh Term | Cholangiocarcinoma | Mesh Term | Adenocarcinoma | Mesh Term | Carcinoma | Mesh Term | Neoplasms, Glandular and Epithelial | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
| Downcase Mesh Term | cholangiocarcinoma | Downcase Mesh Term | adenocarcinoma | Downcase Mesh Term | carcinoma | Downcase Mesh Term | neoplasms, glandular and epithelial | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48186395 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Taiho Oncology, Inc. |
Eligibilities
| Sequence: | 30681814 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Criteria | Inclusion Criteria: Provide written informed consent. >18 years of age. Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory. Patient has failed standard therapy or standard therapy is not tolerated. Has measurable or non-measurable lesion(s). Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Adequate organ function. Exclusion Criteria: History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis. History and/or current evidence of clinically significant ectopic mineralization/calcification. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination. A serious illness or medical condition(s) Pregnant or breast-feeding female |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253882321 |
| Number Of Facilities | 17 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
Intervention Other Names
| Sequence: | 26595807 |
| Intervention Id | 52341058 |
| Name | Futibatinib |
Responsible Parties
| Sequence: | 28795060 |
| Responsible Party Type | Sponsor |