Ignite Creation Date:
2024-05-06 @ 7:57 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02638909
Status:
TERMINATED
Last Update Posted:
2018-04-02
First Post:
2015-12-15
Brief Title:
Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies
Sponsor:
Criterium Inc
Organization:
Criterium Inc
Study Overview
Official Title:
A Phase II Multicenter Single-Arm Study of Oral Ceritinib in Adult Patients With ALK and ROS1 Activated Gastrointestinal Malignancies
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor ALKROS1 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None