Title: A Phase II, Multicenter, Single-Arm Study of Oral Ceritinib in Adult Patients With ALK and ROS1 Activated Gastrointestinal Malignancies1
Principle Investigator: Christopher Lieu, MD, Criterium Inc
Description: For this single-arm, phase 2 study, researchers are investigating the potential of ceritinib among patients with varying types of advanced gastrointestinal cancers with ALK and ROS1 rearrangement who have no available therapeutic options.
Eligible patients must have been pretreated with cytotoxic chemotherapy and have been diagnosed with colorectal adenocarcinoma, cholangiocarcinoma, esophageal, gastric, hepatocellular, or pancreatic adenocarcinoma. ALK or ROS1 activation must be histologically or cytologically confirmed.
The primary endpoint of the study is the 2-month clinical benefit rate of ceritinib, which is defined as the percentage of patients who have a partial response, complete response, or stable disease. Secondary outcome measures include the number of patients who experience treatment-associated adverse events and 2-month objective tumor response.
The estimated enrollment is 30 patients.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02638909.
Status: This study is open and recruiting patients as of September 26, 2017.
This study is sponsored by Criterium Inc in collaboration with Novartis and the University of Colorado, Denver.
- Clinicaltrials.gov. Study of oral ceritinib in patients With ALK and ROS1 activated gastrointestinal malignancies. NCT02638909. https://clinicaltrials.gov/ct2/show/NCT02638909. Accessed September 26, 2017.