Gland and Hormone Related Diseases

All Conditions

Neoplasms

Rare Diseases

Thyroid Diseases

Thyroid Neoplasms

Thyroid Carcinoma, Anaplastic

Carcinoma

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anaplastic Thyroid Cancer

Thyroid Cancer, Medullary

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

sorafenib

Marcia S Brose, MD PhD

The goal of this study is to determine the activity of sorafenib in patients with advanced (metastatic or recurrent) thyroid cancer.

Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer

Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Cancer

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

This is the result of the Kaplan Meier analysis of all patients treated with sorafenib

University of Pennsylvania

Associate Professor

This is a single arm study.

sorafenib: 400mg PO BID daily

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

DIfferentiated

Poorly Differentiated

Medullary

Anaplastic

Histology subtype

ECOG Performance Status 0

ECOG Performance Status 1

Eastern Cooperative Oncology Group (ECOG) performance status is a well known classification system for patient performance status. The scale goes from 0 to 4. With 0 being fully active and functional and a 4 being 100% bedridden.

ECOG Performance Status at Baseline

Four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review.

Dr. Marcia Brose

Differentiated

Poorly Differenitated

Responses were calculated by total enrolled to each group by histologic subtype.

To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.

Progression Free Survival For Entire Study (55 Total Patients)

Of the 59 patients that were consented, four patients were deemed ineligible as a result of inadequate CBC and the establishment of an alternative diagnosis resulting from secondary pathology review. Therefore the total number of patients analyzed going forward was 55.

Median Progression Free Survival in Patients Receiving BAY 43-9006 (Sorafenib).

Overall Study

Amino Acids

Ceritinib

Tyrosine Kinase Inhibitors

Tyrosine

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.

Saad A Khan, MD

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.

Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer

Ceritinib in Mutation and Oncogene Directed Therapy in Metastatic or Locally Advanced Anaplastic/Undifferentiated Thyroid Cancer

Ceritinib will be administered to the patient until disease progression by RECIST (Response Evaluation Criteria In Solid Tumors).

Novartis

University of Texas Southwestern Medical Center

Immunomodulating Agents

Durvalumab

Tremelimumab

Antineoplastic Agents, Immunological

Patients will receive durvalumab (MEDI4736) and tremelimumab together every 4 weeks. SBRT delivered to one metastatic site per standard of care using a standard 9Gy x 3 fractions will be given within 2 weeks after the completion of the first cycle of durvalumab (MEDI4736) and tremelimumab. After 4 cycles of durvalumab (MEDI4736) and tremelimumab, patients will then continue with single agent durvalumab (MEDI4736) every 4 weeks until disease progression or unacceptable toxicity or a total of 12 months from date of initial treatment.

Patients will receive durvalumab (MEDI4736) and tremelimumab together every 4 weeks.

durvalumab

tremelimumab

SBRT at 9Gy x 3 per standard of care given within 2 weeks after the completion of Cycle 1 of durvalumab (MEDI4736) and tremelimumab

Stereotactic Body Radiotherapy (SBRT)

Nancy Lee, MD

The purpose of this study is to test the safety of durvalumab (MEDI4736) and tremelimumab in combination with radiation therapy and find out what effects, if any, this combination has on people, and whether it improves overall survival.

This is a pilot study evaluating durvalumab (MEDI4736) and tremelimumab in combination with standard-of-care stereotactic body radiotherapy (SBRT) in patients with metastatic anaplastic thyroid cancer.

Immunotherapy and Stereotactic Body Radiotherapy (SBRT) for Metastatic Anaplastic Thyroid Cancer

A Pilot Study of Durvalumab (MEDI4736) With Tremelimumab in Combination With Image Guided Stereotactic Body Radiotherapy (SBRT) in the Treatment of Metastatic Anaplastic Thyroid Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania
Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer	NCT02289144	Metastatic Anap... Locally Advance...	Ceritinib	18 Years -	University of Texas Southwestern Medical Center
Immunotherapy and Stereotactic Body Radiotherapy (SBRT) for Metastatic Anaplastic Thyroid Cancer	NCT03122496	Metastatic Anap...	durvalumab tremelimumab Stereotactic Bo...	18 Years -	Memorial Sloan Kettering Cancer Center
Ceritinib in Mutation and Oncogene Directed Therapy in Thyroid Cancer	NCT02289144	Metastatic Anap... Locally Advance...	Ceritinib	18 Years -	University of Texas Southwestern Medical Center
Immunotherapy and Stereotactic Body Radiotherapy (SBRT) for Metastatic Anaplastic Thyroid Cancer	NCT03122496	Metastatic Anap...	durvalumab tremelimumab Stereotactic Bo...	18 Years -	Memorial Sloan Kettering Cancer Center
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer	NCT00654238	Metastatic Diff... Metastatic Poor... Metastatic Anap... Metastatic Medu...	sorafenib	18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for metastatic anaplastic thyroid cancer