MedTrace Logo

Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer

NCT02289144 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-07-30

No results posted yet for this study

Summary

This is an, open-label, protocol designed to evaluate the activity of targeted therapy in anaplastic/undifferentiated thyroid cancer. Arm A will evaluate ATC/UTC 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 1.1, 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 ceritinib's 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.

Conditions

  • Metastatic Anaplastic Thyroid Cancer
  • Locally Advanced Anaplastic, Undifferentiated Thyroid Cancer

Interventions

DRUG

Ceritinib

750 mg orally daily on day 1. Continue every 4 weeks and every 2 cycles (1 Cycle is 28 days long) : until progression, new recurrence or distant metastasis, as well as enlargment of an existing metastasis on radiological Imaging.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Saad A Khan, MD · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02289144 on ClinicalTrials.gov