Status:
ACTIVE_NOT_RECRUITING
A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Lead Sponsor:
Servier
Conditions:
Cholangiocarcinoma Non-resectable
Cholangiocarcinoma Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will enroll participants with nonresectable or metastatic cholangiocarcinoma with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have previously received at least 1, but no mor...
Eligibility Criteria
Inclusion
- Have nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation or ablative therapies
- Have documented IDH1 gene-mutated disease from a tumor biopsy
- Have an ECOG PS score of 0 or 1
- Have an expected survival of 3 months or more
- Have at least one evaluable and measurable lesion
- Have disease progression following the most recent of 1 or 2 prior systemic regimens for advanced disease with progression on the treatment that was most recently given at a minimum, and must have received at least 1 gemcitabine- or 5-FU -containing regimen
- Have recovered from side effects associated with the prior treatment therapy
- Have adequate bone marrow function
- Have adequate hepatic (liver) and renal (kidney) function
- Women of child bearing potential must have a negative serum pregnancy test before starting study treatment, and use birth control during the study and for 90 days after the last dose of ivosidenib
- Fertile men with female partners of child bearing potential must use birth control during the study and for 90 days after the last dose of ivosidenib
Exclusion
- Received a prior IDH inhibitor.
- Have known symptomatic brain metastases requiring steroids.
- Pregnancy, possibility of becoming pregnant during the study and breast-feeding women or woman who plans to restart breast-feeding after the study drug administration/intake.
- Are taking known strong cytochrome P450 (CYP) 3A4 inducers or sensitive CYP3A4 substrate medications with a narrow therapeutic window
- Have significant heart disease, including congestive heart failure, myocardial infarction (heart attack) unstable angina (chest pain) and/or stroke, within 6 months before starting the study
- Have a heart-rate corrected QT interval ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events
- . Have active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis (paralysis of the stomach), or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.
- Have known medical history of progressive multifocal leukoencephalopathy (PML)
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06081829
Start Date
October 10 2023
End Date
May 1 2027
Last Update
December 9 2025
Active Locations (7)
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1
National Cancer Center Hospital East (JPN-002)
Kashiwa, Japan, 277-8577
2
Kumamoto University Hospital (JPN-004)
Kumamoto, Japan, 860-8556
3
National Hospital Organization Shikoku Cancer Center (JPN-007)
Matsuyama, Japan, 791-0280
4
Osaka International Cancer Institute (JPN-005)
Osaka, Japan, 541-8567