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Can a Two-Drug combo shrink Hard-to-Treat thyroid tumors?

NCT ID NCT03099356

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This phase II trial is testing whether two drugs, cyclophosphamide and sirolimus, can help people with metastatic thyroid cancer that has stopped responding to radioactive iodine treatment. Participants take both drugs in monthly cycles, and doctors monitor tumor size and side effects. The goal is to see if the combination can shrink or control the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cyclophosphamide and sirolimus
What this could lead to
If effective, this combination could offer a new treatment option for people with advanced thyroid cancer that no longer responds to standard radioactive iodine therapy.
What could go wrong
This is a small, early-phase trial, so the treatment may not work for everyone and could cause side effects like toxicity. More research would be needed before it becomes a standard therapy.

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

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

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 documented differentiated thyroid cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment * Measurable disease (\>10 mm) and have progression of disease based on RECIST criteria. Previously irradiated tumor lesions are not considered measurable unless they have progressed since radiation. * Previous failure of Iodine-131 (131I) therapy or not candidates to receive 131I as assessed by treating physician. * Age ≥ 18 years * ECOG (Eastern Cooperative Oncology Group) performance status 0-2 * Life expectance of ≥ 12 weeks * 131I therapy not allowed within 24 weeks before entry (4 weeks if negative post-treatment scan) * Adequate organ and marrow function * Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment * Willingness and ability to comply with scheduled visits, treatment plans, including willingness to take study medication, laboratory tests, and other study procedures Exclusion Criteria: * Inability to obtain Foundation One testing on archival tissue, or, lack of previous Next Generation Sequencing * Chemotherapy, tyrosine kinase inhibitor, or radiation therapy within 4 weeks * Prior experimental therapy within 4 weeks of planned start of this trial * 131I therapy within 24 weeks before entry (4 weeks if negative post-treatment scan) * Previous treatment with an mTOR inhibitor * Patients who are currently receiving treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein that cannot be discontinued at least one week prior to the start of treatment with Cyclophosphamide and Sirolimus * Impairment of GI (gastrointestinal) function or GI disease that may significantly alter the absorption of study medications (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection) including dependence on a G-Tube for administration of medications. * A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment * Patients with known sensitivities to either cyclophosphamide and/or sirolimus * Patients with known urinary outflow obstruction * Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol * Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence * Women who are pregnant or breast-feeding * Patients residing in prison

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Michigan Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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