An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501463-40-01

Acronym

DIM-95031-002

Enrollment

202

Registered

2023-04-25

Start date

2023-05-03

Completion date

Unknown

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Cholangiocarcinoma

Brief summary

AEs, serious AEs (SAEs), AEs of special interest (AESIs), AEs leading to discontinuation or death, safety laboratory parameters, 12-lead ECG, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status (PS)

Detailed description

• Response to treatment based on tumor assessments by the investigator according to local clinical practice o Progression-free survival (PFS) o Overall survival (OS) o Duration of response (DOR) o Time to response (TTR), • HRQOL as assessed by the validated European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21), • Health economic outcomes as assessed by the 5 level EuroQol 5-dimensional questionnaire (EQ-5D-5L), • Proportion of days at home or hospital, • Concomitant medications

Interventions

DRUGIVOSIDENIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
AEs, serious AEs (SAEs), AEs of special interest (AESIs), AEs leading to discontinuation or death, safety laboratory parameters, 12-lead ECG, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status (PS)	—

Secondary

Measure	Time frame
• Response to treatment based on tumor assessments by the investigator according to local clinical practice o Progression-free survival (PFS) o Overall survival (OS) o Duration of response (DOR) o Time to response (TTR), • HRQOL as assessed by the validated European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21), • Health economic outcomes as assessed by the 5 level EuroQol 5-dimensional questionnaire (EQ-5D-5L), • Proportion of days at home or hospital, • Concomitant medications	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026