Can a new oral drug outsmart Radioiodine-Resistant thyroid cancer?
NCT ID NCT00936858
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This phase II trial is testing an oral drug called RAD001 (everolimus) in people with advanced thyroid cancer that no longer responds to radioactive iodine treatment. The drug works by blocking a key growth pathway (mTOR) in cancer cells. The study aims to see if RAD001 can slow cancer progression and shrink tumors, potentially offering a new treatment option for this hard-to-treat condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RAD001 (everolimus), an oral drug that blocks the mTOR pathway to potentially slow cancer growth
- What this could lead to
- If this trial succeeds, it could offer a new treatment option for people with thyroid cancer that has stopped responding to radioactive iodine, potentially slowing disease progression.
- What could go wrong
- This is a phase II trial with a small number of participants, so results may not be conclusive. The drug may not be effective for all types of thyroid cancer and could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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50 people
The number who actually took part.
- Started
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Jul 2009
- Finished
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Feb 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed locally advanced or metastatic thyroid cancer, excluding thyroid lymphomas not amenable to or refractory to surgical resection, external beam radiotherapy, radioiodine or other local therapies. * Prior therapy with chemotherapy and targeted therapies except for mTor inhibitors is allowed. * Medullary thyroid cancer with documented evidence of disease progression by modified RECIST within 6 months before study day 1 or symptomatic disease at the time of screening in the absence of documented disease progression. * Differentiated thyroid cancer with documented evidence of disease progression by modified RECIST within 6 months before study day 1. * Anaplastic thyroid cancer with disease progression with documented disease progression by modified RECIST within 6 months of study day 1. * Patients must have at least one measurable site of disease according to RECIST criteria that has not previously irradiated. If the patient has has previous radiation to the marker lesion(s), there must be evidence of progression since radiation. * 18 years of age or older * WHO performance status 2 or less * Adequate bone marrow, liver, and renal function * Fasting serum cholesterol 300mg/dL or less OR 7.75 mmol/L or less AND fasting triglycerides 2.5x ULN or less Exclusion Criteria: * Patients receiving anticancer therapies within last 2 weeks or who have received radiation therapy within 3 weeks of study day 1 * Prior therapy with mTOR inhibitors * Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study * Prior treatment with any investigational drug within the preceding 3 weeks * Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed. * Patients should not receive immunization with attenuated live vaccines within 2 weeks of study entry or during study period * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases * Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * A known history of HIV seropositivity * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 * Patients with an active, bleeding diathesis * Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods * Patients who have received prior treatment wih an mTOR inhibitor * Patients with a known hypersensitivity to RAD001 or other rapamycins or to its excipients * History of noncompliance to medical regimens
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mt. Sinai Medical Center
New York, New York, 10029, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Thyroid surgery under the microscope: what 3,000 real operations reveal