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Lower drug dose may offer same benefit with fewer side effects for thyroid cancer patients

NCT ID NCT01896479

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a lower dose (60 mg) of the drug cabozantinib works as well as the standard higher dose (140 mg) in people with progressive, metastatic medullary thyroid cancer. The goal is to see if the lower dose can control cancer growth for a similar length of time while causing fewer side effects. About 247 participants took either the lower or higher dose daily, and researchers compared how long their cancer stayed stable.

What this could mean

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

Active substance
cabozantinib (XL184)
What this could lead to
If successful, this could show that a lower dose of cabozantinib works just as well as the higher dose but with fewer side effects, improving quality of life for patients.
What could go wrong
This is a phase 4 study comparing two known doses, so it is not testing a new treatment. The lower dose may prove less effective in controlling cancer progression.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

247 people

The number who actually took part.

Started

Feb 2015

Expected to finish

Jan 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. The subject has a histologically confirmed diagnosis of MTC. 2. All subjects will need to be tested for RET mutational status. If subjects do not have documentation confirming they have a RET mutation, a sample of their tumor (taken either during screening or from a procedure within 6 months prior to randomization) will need to be tested. 3. The subject has measurable disease per RECIST 1.1 that is metastatic as determined by the investigator based upon computerized tomography (CT), magnetic resonance imaging (MRI), PET scan, bone scan, or X-ray taken within 28 days before randomization. 4. The subject has documented worsening of disease (progressive disease) at screening as compared with a previous CT, PETor MRI scan, bone scan, or X-ray as determined by the investigator per RECIST 1.1 on qualifying screening images taken within 28 days prior to randomization as compared to previous images taken within 14 months before the qualifying screening images. 5. The subject has recovered to baseline or CTCAE v4.0 (Common Terminology Criteria for Adverse Events, version 4.0) ≤ Grade 1 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy. 6. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. 7. The subject has adequate organ and marrow function 8. The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document. 9. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment. Exclusion Criteria: 1. The subject has previously received cabozantinib. 2. Receipt of any type of small molecule kinase inhibitor or hormonal therapy within 28 days or 5 half-lives of the compound or active metabolites, whichever is shorter, before randomization. 3. Receipt of any systemic anti-tumor therapy within 28 days of randomization (42 days for nitrosoureas or/ mitomycin C). 4. Receipt of any other type of investigational agent within 28 days of randomization. 5. Receipt of radiation therapy within 28 days (14 days for radiation for bone metastases) of randomization or radionuclide treatment within 42 days of randomization. Subject is ineligible if there are any clinically relevant ongoing complications from prior radiation therapy. 6. The subject has untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis. Must have completed radiation therapy ≥ 28 days prior to randomization and be stable without corticosteroids or anti-convulsant treatment for ≥ 10 days. 7. Treatment at therapeutic doses with oral anticoagulants or platelet inhibitors (examples are warfarin and clopidogrel). 8. The subject has uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery. 9. Corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms within 28 days before randomization. 10. The subject is unable to swallow multiple tablets or capsules. 11. The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation. 12. The subject is pregnant or breastfeeding. 13. The subject has had a diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy.

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Conditions

The condition(s) this trial relates to.

Carcinoma, Medullary medullary thyroid gland carcinoma Thyroid Neoplasms

As listed by the trial registrant

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

Contacts and locations

Locations

  • Study site

    St Leonards, New South Wales, 2065, Australia

  • Study site

    Herston, Queensland, 4006, Australia

  • Study site

    Kurralta Park, South Australia, 5037, Australia

  • Study site

    Parkville, Victoria, 3050, Australia

  • Study site

    Québec, Quebec, JIH 5N4, Canada

  • Study site

    Toronto, M5G 2M9, Canada

  • Study site

    Osijek, 31000, Croatia

  • Study site

    Zagreb, 10000, Croatia

  • Study site

    Zagreb, 1000, Croatia

  • Study site

    Bordeaux, Gironde, 33076, France

  • Study site

    Angers, Maine-et-Loire, 49933, France

  • Study site

    Lyon, Rhône, 69373, France

  • Study site

    Villejuif, Val-de-Marne, 94805, France

  • Study site

    Dijon, 21079, France

  • Study site

    Paris, 75013, France

  • Study site

    Strasbourg, 67065, France

  • Study site

    Budapest, 1088, Hungary

  • Study site

    Debrecen, 4032, Hungary

  • Study site

    Jerusalem, 91120, Israel

  • Study site

    Petah Tikva, 49100, Israel

  • Study site

    Safed, 13100, Israel

  • Study site

    Catania, CT, 95124, Italy

  • Study site

    Roma, RM, 00161, Italy

  • Study site

    Siena, SI, 53100, Italy

  • Study site

    Pisa, Tuscany, 56124, Italy

  • Study site

    Milan, 20133, Italy

  • Study site

    Padua, 35138, Italy

  • Study site

    Torino, 10153, Italy

  • Study site

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Study site

    Leiden, South Holland, 2333 ZA, Netherlands

  • Study site

    Groningen, 9713 GZ, Netherlands

  • Study site

    Poznan, Greater Poland Voivodeship, 60-355, Poland

  • Study site

    Gliwice, Silesian Voivodeship, 44-100, Poland

  • Study site

    Bucharest, 10825, Romania

  • Study site

    Bucharest, 11863, Romania

  • Study site

    Cluj-Napoca, 400058, Romania

  • Study site

    Timișoara, 300723, Romania

  • Study site

    Novosibirsk, 630068, Russia

  • Study site

    Obninsk, 249036, Russia

  • Study site

    Saint Petersburg, 197089, Russia

  • Study site

    Yaroslavl, 150040, Russia

  • Study site

    Goyang, Gyeonggido, 410769, South Korea

  • Study site

    Seoul, 110744, South Korea

  • Study site

    Seoul, 135-710, South Korea

  • Study site

    Barcelona, 08035, Spain

  • Study site

    Madrid, 28034, Spain

  • Study site

    Madrid, 28046, Spain

  • Study site

    Lund, Skane Ian, SE-22185, Sweden

  • Study site

    Uppsala, Uppsala Ian, 75185, Sweden

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