Pretreated locally advanced or metastatic cholangiocarcinoma (CCA)
Conditions
Interventions
To receive ivosidenib orally at a dose of 500 mg once daily (QD).
Sponsors
Yamamoto Kayo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have a histopathological diagnosis of CCA consistent with nonresectable or metastatic CCA and are not eligible for curative-intent resection, transplantation, or ablative therapies -Have documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease based on a local validated biomolecular profiling method -Have documented locally advanced or metastatic CCA following at least 1 prior line of systemic therapy -Have recovered from toxicities associated with prior anticancer therapy to baseline or have stabilized under medical management -Female patients with reproductive potential must have a negative serum pregnancy test prior to the start of the study treatment, or a confirmation from an obstetrician in case of equivocal serum pregnancy results. Females of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion or who have not been naturally postmenopausal (ie, who have not menstruated) for at least 24 consecutive months (ie, have not had menses at any time in the preceding 24 consecutive months). Women of reproductive potential, as well as fertile men with partners who are female with reproductive potential, must agree to use effective form of contraception from the time of giving informed consent throughout the study and for 3 months (both females and males) following the last dose of study treatment. Effective form of contraception is defined by using a barrier method (condoms).
Exclusion criteria
Exclusion criteria: -Received a prior IDH1 inhibitor -Had a prior transplantation -Received systemic anticancer therapy <2 weeks prior to first dose of study treatment on C1D1 -Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to C1D1 -Have known symptomatic brain metastases requiring steroids. -Underwent major surgery <4 weeks prior to C1D1 -Have known active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness. -Are pregnant or breastfeeding
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 - Progression-free survival (PFS) - Overall survival (OS) - Duration of response (DOR) - Time to response (TTR) Proportion of days at home or hospital Concomitant medications | — |
Countries
Armenia, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Japan, Netherlands, Romania, South Korea, Spain, Sweden, United Kingdom
Contacts
Public ContactKayo Yamamoto
Syneos Health Japan K.K.
Outcome results
None listed