Study:
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
Rationale:
n/a
Purpose:
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.
Study Status: Recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Thyroid Cancer |
Drug: Everolimus
Drug: Pasireotide
Drug: Everolimus and Pasireotide |
Phase 2 |
Verified by
Emory University
July, 2011
Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov identifier: NCT01270321
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic, Taussig Cancer Center
Cleveland, Ohio 44195
United States
Taofeek Owonikoko, PhD, MD., Principal Investigator