Metastatic Anaplastic Thyroid Cancer Clinical Trial
Official title:
Ceritinib in Mutation and Oncogene Directed Therapy in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer
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.
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.
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 PET/MRI 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00654238 -
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer
|
Phase 2 | |
| Completed |
NCT03122496 -
Immunotherapy and Stereotactic Body Radiotherapy (SBRT) for Metastatic Anaplastic Thyroid Cancer
|
Phase 1 |