Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04507503 |
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Expanded Access Status :
Available
First Posted : August 11, 2020
Last Update Posted : January 4, 2023
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Sponsor:
Taiho Oncology, Inc.
Information provided by (Responsible Party):
Taiho Oncology, Inc.
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| Tracking Information | |||||
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| First Submitted Date | August 7, 2020 | ||||
| First Posted Date | August 11, 2020 | ||||
| Last Update Posted Date | January 4, 2023 | ||||
| Descriptive Information | |||||
| Brief Title | Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements | ||||
| Brief Summary | The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements. | ||||
| Detailed 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. | ||||
| Study Type | Expanded Access | ||||
| Expanded Access Type | Treatment IND/Protocol | ||||
| Intervention | Drug: TAS-120
Futibatinib 20mg QD orally on a 28 days cycle
Other Name: Futibatinib
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Expanded Access Status | Available | ||||
| Contacts |
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| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04507503 | ||||
| Current Responsible Party | Taiho Oncology, Inc. | ||||
| Original Responsible Party | Same as current | ||||
| Current Study Sponsor | Taiho Oncology, Inc. | ||||
| Original Study Sponsor | Same as current | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Taiho Oncology, Inc. | ||||
| Verification Date | January 2023 | ||||