At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histopathologically confirmed nonresectable or metastatic cholangiocarcinoma not eligible for curative resection, transplantation, or ablative therapies
- ✓Documented IDH1 mutation (R132C/L/G/H/S variants) confirmed by central laboratory testing
- ✓Disease progression after 1-2 prior systemic regimens for advanced disease, with at least 1 gemcitabine- or 5-FU-containing regimen required
- ✕Prior IDH inhibitor therapy
- ✕Symptomatic brain metastases requiring steroids
- ✕Systemic anticancer therapy or investigational agent within 2 weeks prior to Day 1 (4 weeks for immune-based therapy)
- ✕Radiotherapy to metastatic sites within 2 weeks prior to Day 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
In Brief
A Phase 3 clinical trial evaluating AG-120 and Placebo for Advanced Cholangiocarcinoma and Metastatic Cholangiocarcinoma. Completed, enrolled 187 participants across 49 sites in 6 countries.
Detailed Summary
Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.
Study Details
Timeline
Interventions
Tablet administered orally
Tablet administered orally