An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
Recruiting
Phase 3
Interventional Study
Cholangiocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 220 (estimated)
- Sponsor
- Servier Affaires Médicales · Industry
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About This Trial
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. Th…
Trial Locations
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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 system…
Contacts
Institut de Recherches Internationales Servier, Clinical Studies Department
+33 1 55 72 60 00
scientificinformation@servier.com
CONTACT