Conditions: Head and Neck Cancer Liver Cancer Breast Cancer Gastric Cancer Non-Small Cell Lung Cancer
Keywords: Head and Neck Cancer Liver Cancer Breast Cancer Gastric Cancer Non-Small Cell Lung Cancer EGFR HDAC Her2 CUDC-101
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief summary:
This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to compare the safety and tolerability of CUDC-101 when administered at the maximum tolerated dose on either a 5 days/week schedule or a 3 days/week schedule.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: CUDC-101 intervention 2: CUDC-101
Intervention descriptions: intervention 1: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle. intervention 2: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.

Protocol document: