Neoplasms

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Thyroid Cancer, Medullary

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Pasireotide

Somatostatin

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Hormones

Hormone Antagonists

CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression

CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression

Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)

Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks

Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks

Everolimus and Pasireotide

Taofeek Owonikoko, MD, PhD

The purpose of this study is to determine the effectiveness of two anticancer drugs, everolimus and pasireotide, in patients with thyroid cancer when the cancer is no longer responding to treatment with radioiodine or where it is deemed unsafe for the patient to receive additional radioiodine treatment. The investigators also want to establish the best manner of taking the two medications when used together to treat thyroid cancer. In particular, the investigators want to know if it is better to give both at the same time or add a second medication after the first one has stopped working.

This study will also look at specific substances called biomarkers in your blood, and in the tumor tissue which are involved in the growth of tumor cells, and determine if the levels of these biomarkers are related to your response to treatment or development of side effects.

Everolimus, also known by the brand name, Afinitor, is a biologic drug approved by the Food and Drug Administration (FDA) for the treatment of kidney cancer. It works by preventing cancer cells from multiplying and it also makes them more likely to die from the treatment.

Pasireotide also known by the name, SOM230 is a new medication that is not yet approved by the FDA for the treatment of cancer. It is a newer form of a drug called octreotide, which is approved for the treatment of cancer arising from endocrine organs. Pasireotide works by binding to a protein called somatostatin receptor, which is expressed in many tissues throughout the body including thyroid cancer cells. Pasireotide prevents the action of somatostatin by binding to these receptors.

Pasireotide & Everolimus in Adult Patients With Radioiodine-Refractory Differentiated & Medullary Thyroid Cancer

A 3-Arm Randomized Phase II Trial Evaluating Single Agent and Combined Efficacy of Pasireotide and Everolimus in Adult Patients With Radioiodine-Refractory Differentiated and Medullary Thyroid Cancer

Number of participants with response 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."

Time from starting treatment until disease progression as defined using Response Evaluation CriteriaIn Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or death.

Novartis

Emory University

Principal Investigator

Any undesirable any unfavorable signs or symptom reported by the patient while on study drug .

CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression

Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)

Arm A (Everolimus Alone)

CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression

Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks

Arm B (Pasireotide Alone)

CURRENTLY CLOSED TO ACCRUAL

Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks

Arm C (Everolimus + Pasireotide)

Total

Age, Categorical

The measure of dispersion data are not available. All efforts were made to obtain these data from the PI and the study documentation.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Taofeek Owonikoko

CURRENTLY CLOSED TO ACCRUAL--Everolimus alone followed by Everolimus + Pasireotide at the time of progression

Everolimus: Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)

Most frequent adverse events in \>20% of patients:

* Dry skin
* Dysgeusia
* Hypoalbuminemia
* Joint Pain
* Cough
* Diarrhea
* Hypercholesterolemia
* Hypertriglceridemia
* Hypokalemia
* Hyponatremiapnia
* Mucositis
* Rash
* Thrombocyto

CURRENTLY CLOSED TO ACCRUAL--Pasireotide alone followed by Everolimus + Pasireotide at the time of progression

Pasireotide: Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks.

Most frequent adverse events in \>20% of patients:

* Hyperbilirubinemia
* Hypertriglyceridemia
* Hypercholesterolemia

CURRENTLY CLOSED TO ACCRUAL

Everolimus and Pasireotide: Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks.

Most frequent adverse events in \>20% of patients:

* Hypercholesterolemia
* Anemia
* Headache
* Decreased Appetite
* Cough
* Mucositis
* Hyponatremia

Spots Global Cancer Trial Database for everolimus and pasireotide