2022-501463-40-01RecruitingPhase 3
An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Servier Affaires Medicales58 sites in 10 countries202 target enrollmentStarted: April 25, 2023Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Servier Affaires Medicales
- Enrollment
- 202
- Locations
- 58
- Primary Endpoint
- 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)
Study Overview
Brief Summary
Safety of ivosidenib in patients with pretreated locally advanced or metastatic CCA
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Treatment Period
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Be ≥18 years of age
- •Be able to understand and willing to sign the informed consent form (ICF) and to comply with the study procedures.
- •Willingness to comply with contraception guidelines of this study.
- •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 an ECOG PS score of 0 or 1
- •Have recovered from toxicities associated with prior anticancer therapy to baseline or have stabilized under medical management
- •Have adequate bone marrow function as described in the protocol.
- •Have adequate hepatic function as described in the protocol.
- •Have adequate renal function as described in the protocol.
Exclusion Criteria
- •Received a prior IDH1 inhibitor
- •Are taking known strong cytochrome P450 (CYP) 3A4 inducers or inhibitors or sensitive CYP3A4 substrate medications, unless they can be transferred to other medications.
- •Are taking P-glycoprotein (P-gp) transporter-sensitive substrate medications or inhibitors unless they can be transferred to other medications.
- •Have an active infection requiring systemic anti-infective therapy or with an unexplained fever >38.5°C within 7 days of Day
- •Have any known hypersensitivity to any of the components of ivosidenib
- •Have significant active cardiac disease within 6 months prior to the start of study treatment.
- •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.
- •Have any gastrointestinal medical condition which would limit ingestion or gastrointestinal absorption according to investigator’s judgment
- •Had a prior transplantation
- •Received systemic anticancer therapy <2 weeks prior to first dose of study treatment on C1D1, immune based anticancer therapy <4 weeks prior to C1D1, or an investigational agent <5 half-lives of this agent prior to C1D1
- •Received radiotherapy to metastatic sites of disease <2 weeks prior to C1D1
- •Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to C1D1
- •Have known symptomatic brain metastases requiring steroids.
- •Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid or liquid tumor with no known active disease present that, in the opinion of the Investigator, will not affect patient outcome in the setting of current CCA diagnosis.
- •Underwent major surgery <4 weeks prior to C1D1 or have not recovered from post-surgery toxicities
- •Are pregnant or breastfeeding
Outcomes
Primary Outcomes
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)
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 Outcomes
- • 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
Investigators
Global Evidence Generation Lead
Scientific
Servier Affaires Medicales
Study Sites (58)
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