Conditions: Solid Tumor Glioma Angioimmunoblastic T-cell Lymphoma Intrahepatic Cholangiocarcinoma Chondrosarcoma
Keywords: solid tumor intrahepatic cholangiocarcinoma chondrosarcoma angioimmunoblastic T-cell lymphoma AITL IDH glioma solid tumor, including intrahepatic cholangiocarcinoma and chondrosarcoma
Allocation: NA | Intervention model: SEQUENTIAL
Enrollment: 21
Healthy volunteers: no

Brief 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.

Detailed description:
The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of enasidenib to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose. The second portion of the study is a planned dose expansion phase where three cohorts of patients will receive enasidenib to further evaluate the safety, tolerability, and clinical activity. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Enrollment into the AG221-C-003 study was closed following enrollment of the dose escalation Cohort 4 (650 mg QD) in order to focus resources on the development of other pipeline IDH inhibitors in solid tumors, gliomas, and lymphoma; it was not due to safety reasons. Participants receiving enasidenib at the time of study closure were to be allowed to continue treatment until disease progression or the development of unacceptable toxicity, as outlined in the study protocol.

Arms:
arm 1: During the dose escalation phase, consented eligible participants will be enrolled into sequential cohorts of increasing doses of enasidenib.The starting dose for this study is 100 mg administered every 24 hours,

Interventions: intervention 1: Enasidenib
Intervention descriptions: intervention 1: Enasidenib tablets administered orally once a day in 28-day treatment cycles until disease progression or unacceptable toxicities.

Protocol document: