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Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04507503
Expanded Access Status : Approved for marketing
First Posted : August 11, 2020
Last Update Posted : February 23, 2024
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Tracking Information
First Submitted Date August 7, 2020
First Posted Date August 11, 2020
Last Update Posted Date February 23, 2024
 
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
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 February 2024