NCT05876754 An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
| NCT ID | NCT05876754 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Servier Affaires Médicales |
| Condition | Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-05-03 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 220 participants in total. It began in 2023-05-03 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies * Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease * Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects * Female patients of childbearing potential must have a negative blood pregnancy test prior to starting treatment and must agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug * Male patients with a female partner with childbearing potential must also agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug Exclusion Criteria: * Received a prior IDH1 inhibitor * Have received a transplant * Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1 * Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1 * Have ongoing brain metastases requiring steroids * Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1 * Have an 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
Contact & Investigator
Institut de Recherches Internationales Servier, Clinical Studies Department
✉ scientificinformation@servier.com📞 +33 1 55 72 60 00
Frequently Asked Questions
Who can join the NCT05876754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05876754 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 220 participants.
Is NCT05876754 currently recruiting?
Yes, NCT05876754 is actively recruiting participants. Contact the research team at scientificinformation@servier.com for enrollment information.
Where is the NCT05876754 trial being conducted?
This trial is being conducted at Yerevan, Armenia, Yerevan, Armenia, Brisbane, Australia, Fitzroy, Australia and 11 additional locations.
Who is sponsoring the NCT05876754 clinical trial?
NCT05876754 is sponsored by Servier Affaires Médicales. The trial plans to enroll 220 participants.