Viewing Study NCT02289144



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Last Modification Date: 2024-10-26 @ 11:33 AM
Study NCT ID: NCT02289144
Status: WITHDRAWN
Last Update Posted: 2019-07-30
First Post: 2014-10-06

Brief Title: Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer
Sponsor: University of Texas Southwestern Medical Center
Organization: University of Texas Southwestern Medical Center

Study Overview

Official Title: Ceritinib in Mutation and Oncogene Directed Therapy in Metastatic or Locally Advanced AnaplasticUndifferentiated Thyroid Cancer
Status: WITHDRAWN
Status Verified Date: 2019-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: study was on hold for protocol redesign decided to not move forward with study
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is an open-label protocol designed to evaluate the activity of targeted therapy in anaplasticundifferentiated thyroid cancer Arm A will evaluate ATCUTC with mutations or rearrangements detected in the ALK gene

There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or metastatic setting Ceritinib will be administered to the patient until disease progression by RECIST 11 unacceptable toxicity withdrawal of consent or discontinuation of the trial for any other reason

The primary focus of this arm of the protocol is identifying ceritinibs activity in anaplastic or undifferentiated thyroid cancer patients Those patients with mutations identified in their ALK gene by sequencing their tumor samples or with the established ALK abnormalities will be treated with ALK-inhibitors These include the Ventana assay and Vysis FISH probe and patients with tumors positive by this assay will also be considered eligible for therapy on the trial

Therapeutic Portion

ARM A ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2 cycles

Primary Endpoint The development of progression new recurrence or distant metastasis as well as enlargement of an existing metastasis on radiographic imaging

Secondary Endpoints

1 Overall response rate for patients treated with ceritinib as part of the study
2 Death of study participant due to any cause
Detailed Description: This is an open-label protocol designed to evaluate the activity of targeted therapy in anaplasticundifferentiated thyroid cancer Arm A will evaluate ATCUTC with mutations or rearrangements detected in the ALK gene

There is no effective treatment for anaplastic thyroid cancer in the locally recurrent or metastatic setting Ceritinib will be administered to the patient until disease progression by RECIST 11 unacceptable toxicity withdrawal of consent or discontinuation of the trial for any other reason

The primary focus of this arm of the protocol is identifying ceritinibs activity in anaplastic or undifferentiated thyroid cancer patients Those patients with mutations identified in their ALK gene by sequencing their tumor samples or with the established ALK abnormalities will be treated with ALK-inhibitors These include the Ventana assay and Vysis FISH probe and patients with tumors positive by this assay will also be considered eligible for therapy on the trial

The goal of this multi-center multi-arm trial is to measure the impact of treating metastatic anaplastic thyroid cancer patients with targeted therapy selected for these patients due the presence of a genetic mutation or other aberration This trial will serve as a framework by which new biomarker-drug combinations can be identified and added as new arms

Therapeutic Portion

ARM A ALK Abnormality IND Ceritinib 750 mg orally daily on Day 1 Continue q4 weeks x 2 cycles

Primary Endpoint The development of progression new recurrence or distant metastasis as well as enlargement of an existing metastasis on radiographic imaging CT scans of the neck chest abdomen and pelvis will be performed at baseline and every two cycles cycles are 28 days long according to standard of care Other imaging of these areas such as PETMRI will be allowed if CT cannot be performed MRI of the brain will be performed at baseline and as clinically indicated Wherever it can be safely given radiographic contrast agents should be given for the imaging studies

Secondary Endpoints

1 Overall response rate for patients treated with ceritinib as part of the study
2 Death of study participant due to any cause

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