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Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Study acronym: FOENIX-CCA4
StatusRecruiting
PhasePhase 2
Started2023-07-05
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Status, Contacts/Locations v28
Study sitesdetails revised at 5 of 65 sites
2026-07-27
Study Status, Contacts/Locations v27
Study sitesdetails revised at 42 of 65 sites
2026-06-25
Study Status, Contacts/Locations v26
Study sitesdetails revised at 7 of 65 sites
2026-05-27
Study Status, Contacts/Locations v25
Study sitesdetails revised at 2 of 65 sites
2025-12-24
Study Status, Contacts/Locations v24
Study sitesdetails revised at 2 of 65 sites
Show 23 earlier versions
2025-12-04
Study Status, Contacts/Locations v23
Study sites63→65
2025-10-30
Study Status, Contacts/Locations v22
Study sitesdetails revised at 2 of 63 sites
2025-10-01
Study Status, Contacts/Locations v21
Study sites59→63
2025-06-30
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 59 sites
2025-06-03
Study Status, Contacts/Locations v19
Study sites57→59
2025-03-31
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 57 sites
2025-01-30
Study Status, Contacts/Locations v17
Primary completion date2025-06→2026-12
Completion date2026-06→2026-12
Study sites56→57
2025-01-05
Study Status v16
Re-verified, no change to tracked fields
2024-11-29
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 56 sites
2024-10-30
Study Status, Contacts/Locations v14
Study sitesdetails revised at 3 of 56 sites
2024-09-30
Study Status, Contacts/Locations v13
Study sites52→56
2024-08-30
Study Status, Contacts/Locations v12
Start date2023-05-12→2023-07-05
Study sites51→52
2024-07-31
Study Status, Contacts/Locations v11
Study sitesdetails revised at 10 of 51 sites
2024-06-25
Study Status, Contacts/Locations v10
Re-verified, no change to tracked fields
2024-05-21
Study Status, Contacts/Locations v9
Study sites51 entries, revised
Shanghai EastGobroad Cancer Hospital China Pharmaceutical University
2024-04-11
Study Status, Contacts/Locations v8
Study sitesdetails revised at 11 of 51 sites
2024-04-10
Study Status, Contacts/Locations v7
Study sites49→51
2024-03-07
Study Status, Contacts/Locations v6
Study sitesdetails revised at 18 of 49 sites
2024-01-12
Study Status, Contacts/Locations v5
Study sites44→49
2023-12-20
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 44 sites
2023-10-04
Study Status, Contacts/Locations v3
Study sites1→44
2023-06-13
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04-14→confirmed 2023-05-12
Study sites0→1
2023-03-22
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields
2023-02-03
Original filing
This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.
Trial Details
NCT Number NCT05727176
Lead Sponsor Taiho Oncology, Inc.
Conditions Advanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement
Enrollment 120 participants
Start Date 2023-07-05
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-01