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

NCT02638909 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-04-02

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER
  • Novartis

    collaborator INDUSTRY
  • Criterium, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Lieu, MD · Criterium Inc., d.b.a. Academic GI Cancer Consortium (AGICC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-03-29
Completion
2018-03-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02638909 on ClinicalTrials.gov