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NCT04507503 Clinical Trial

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

Advanced Cholangiocarcinoma Clinical Trial

Official title:
An Open-Label Expanded Access Program of Futibatinib (TAS-120) In Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT04507503
Other study ID # TAS-120-401
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date February 2024
Source Taiho Oncology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The objective of the study is to provide access to TAS-120 to patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements.

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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provide written informed consent. 2. >18 years of age. 3. Histologically confirmed, locally advanced, or metastatic, or recurrent unresectable CCA harboring FGFR2 gene rearrangements based on testing performed by a qualified (CLIA-certified) laboratory. 4. Patient has failed standard therapy or standard therapy is not tolerated. 5. Has measurable or non-measurable lesion(s). 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 7. Adequate organ function. Exclusion Criteria: 1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis. 2. History and/or current evidence of clinically significant ectopic mineralization/calcification. 3. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination. 4. A serious illness or medical condition(s) 5. Pregnant or breast-feeding female

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TAS-120
Futibatinib 20mg QD orally on a 28 days cycle

Locations
Country Name City State
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Chicago Chicago Illinois
United States Duke University Medical Center Durham North Carolina
United States Banner MD Anderson Gilbert Arizona
United States Aurora Cancer care Grafton Wisconsin
United States MD Anderson Houston Texas
United States University of Kansas Cancer Center Lee's Summit Missouri
United States Mount Sinai Center of Florida Miami Beach Florida
United States Advent Health Orlando Orlando Florida
United States Providence Portland Medical Center Portland Oregon
United States Utah Cancer Specialists Salt Lake City Utah
United States University of California, San Francisco (UCSF) San Francisco California
United States UCLA Division of Hematology-Oncology Santa Monica California
United States Seattle Cancer Care Alliance Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Taiho Oncology, Inc.

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
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Recruiting NCT05727176 - Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement Phase 2
Recruiting NCT05791448 - AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease Phase 1
Active, not recruiting NCT04093362 - Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements Phase 3
Recruiting NCT03996408 - Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma Phase 1/Phase 2
Terminated NCT02982720 - Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron Phase 2
Terminated NCT02150967 - A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma Phase 2
Recruiting NCT03982680 - Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma Phase 2
Recruiting NCT05532059 - Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients With Advanced Cholangiocarcinoma Phase 2
Terminated NCT04088188 - Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma Phase 1
Completed NCT02989857 - Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) Phase 3
Recruiting NCT05805956 - IMM2902 in Patients With Advanced Solid Tumors Expressing HER2 Phase 1/Phase 2
Terminated NCT03773302 - Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations Phase 3