At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 21 enrolled
Drug / intervention
Enasidenibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study of AG-221 in Subjects With Advanced Solid Tumors, Including Glioma, and With Angioimmunoblastic T-cell Lymphoma, That Harbor an IDH2 Mutation
In Brief
A Phase 2 clinical trial evaluating Enasidenib for Solid Tumor and 4 related conditions. Completed, enrolled 21 participants across 12 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and clinical activity of enasidenib in adults with advanced solid tumors, including glioma, or with angioimmunoblastic T-cell lymphoma (AITL), with an isocitrate dehydrogenase-2 (IDH2) mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Glioma, Angioimmunoblastic T-cell Lymphoma, Intrahepatic Cholangiocarcinoma, Chondrosarcoma
CountriesFrance, United States
CollaboratorsCelgene Corporation
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartDec 2014
Primary CompletionJun 2016
TodayJul 2026
First PostedOct 24, 2014
Enrollment StartDec 8, 2014
Primary CompletionJun 3, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.7 years ago
Interventions
Enasidenibdrug
Enasidenib tablets administered orally once a day in 28-day treatment cycles until disease progression or unacceptable toxicities.