NCT02638909

Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies

A Phase II, Multicenter, Single-Arm Study of Oral Ceritinib in Adult Patients With ALK and ROS1 Activated Gastrointestinal Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Criterium, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The available data indicate that Ceritinib has substantial anti-tumor activity in patients with anaplastic lymphoma kinase (ALK) and ROS1 rearranged non-small cell lung cancer (NSCLC). This trial will investigate the potential of Ceritinib in patients with advanced gastrointestinal malignancies with ALK and ROA1 rearrangement, and for whom there is no available therapeutic option.

Detailed description

This is a single-arm, open-label, multicenter, phase II study of ceritinib in adult patients with ALK- and ROS1 activated colorectal, cholangiocarcinoma, pancreatic, hepatic, gastric, or esophageal adenocarcinoma. An estimated 500 patients will be screened for ALK and ROS1 by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) per institutional standard of care (SOC), and/or ALK/ROS1 by next-generation sequencing (NGS). At least 30 identified patients will be treated with ceritinib per protocol. Treatment with ceritinib will continue until patient experiences unacceptable toxicity that precludes further treatment, discontinues treatment at the discretion of the investigator or patient, starts a new anticancer therapy and/or dies. Male and female patients aged 18 or over that have colorectal adenocarcinoma, cholangiocarcinoma, pancreatic, hepatocellular, gastric or esophageal adenocarcinoma that contain an activated ALK gene due to rearrangement, mutation, amplification, translocation or other mechanisms. Patients must have been pretreated with cytotoxic chemotherapy.

Conditions

• Colorectal Adenocarcinoma
• Cholangiocarcinoma
• Pancreatic Adenocarcinoma
• Hepatocellular Adenocarcinoma
• Gastric Adenocarcinoma
• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ceritinib	Treatment with ceritinib will continue until patient experiences unacceptable toxicity that precludes further treatment, discontinues treatment at the discretion of the investigator or patient, starts a new anticancer therapy and/or dies.

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-03-29
• Completion: 2018-03-29
• First posted: 2015-12-23
• Last updated: 2018-04-02

Locations

6 sites across 1 country: United States