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Can a new oral drug outsmart Radioiodine-Resistant thyroid cancer?

NCT ID NCT00936858

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Jul 2009

Finished

Feb 2020

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

thyroid cancer Thyroid Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • 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.