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An early access study of ivosidenib in patients with a pretreated locally advanced or metastatic cholangiocarcinoma
EU CTIS ID: 2022-501463-40-00
What this study is testing
Safety of ivosidenib in patients with pretreated locally advanced or metastatic CCA
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Be ≥18 years of age
- 10. Be able to understand and willing to sign the informed consent form (ICF) and to comply with the study procedures.
- 11. Willingness to comply with contraception guidelines of this study.
- 2. Have a histopathological diagnosis of CCA consistent with nonresectable or metastatic CCA and are not eligible for curative-intent resection, transplantation, or ablative therapies
- 3. Have documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease based on a local validated biomolecular profiling method
- 4. Have documented locally advanced or metastatic CCA following at least 1 prior line of systemic therapy
You likely can't join if
- 1. Received a prior IDH1 inhibitor
- 10. Are taking known strong cytochrome P450 (CYP) 3A4 inducers or inhibitors or sensitive CYP3A4 substrate medications, unless they can be transferred to other medications.
- 11. Are taking P-glycoprotein (P-gp) transporter-sensitive substrate medications or inhibitors unless they can be transferred to other medications.
- 12. Have an active infection requiring systemic anti-infective therapy or with an unexplained fever >38.5°C within 7 days of Day 1.
- 13. Have any known hypersensitivity to any of the components of ivosidenib
- 14. Have significant active cardiac disease within 6 months prior to the start of study treatment.
See the full eligibility criteria
Who can join
- 1. Be ≥18 years of age
- 10. Be able to understand and willing to sign the informed consent form (ICF) and to comply with the study procedures.
- 11. Willingness to comply with contraception guidelines of this study.
- 2. Have a histopathological diagnosis of CCA consistent with nonresectable or metastatic CCA and are not eligible for curative-intent resection, transplantation, or ablative therapies
- 3. Have documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease based on a local validated biomolecular profiling method
- 4. Have documented locally advanced or metastatic CCA following at least 1 prior line of systemic therapy
- 5. Have an ECOG PS score of 0 or 1
- 6. Have recovered from toxicities associated with prior anticancer therapy to baseline or have stabilized under medical management
- 7. Have adequate bone marrow function as described in the protocol.
- 8. Have adequate hepatic function as described in the protocol.
- 9. Have adequate renal function as described in the protocol.
What rules you out
- 1. Received a prior IDH1 inhibitor
- 10. Are taking known strong cytochrome P450 (CYP) 3A4 inducers or inhibitors or sensitive CYP3A4 substrate medications, unless they can be transferred to other medications.
- 11. Are taking P-glycoprotein (P-gp) transporter-sensitive substrate medications or inhibitors unless they can be transferred to other medications.
- 12. Have an active infection requiring systemic anti-infective therapy or with an unexplained fever >38.5°C within 7 days of Day 1.
- 13. Have any known hypersensitivity to any of the components of ivosidenib
- 14. Have significant active cardiac disease within 6 months prior to the start of study treatment.
- 15. 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.
- 16. Have any gastrointestinal medical condition which would limit ingestion or gastrointestinal absorption according to investigator’s judgment
- 2. Had a prior transplantation
- 3. 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
- 4. Received radiotherapy to metastatic sites of disease <2 weeks prior to C1D1
- 5. Underwent hepatic radiation, chemoembolization, and radiofrequency ablation <4 weeks prior to C1D1
- 6. Have known symptomatic brain metastases requiring steroids.
- 7. 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.
- 8. Underwent major surgery <4 weeks prior to C1D1 or have not recovered from post-surgery toxicities
- 9. Are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.