Lower drug dose may offer same benefit with fewer side effects for thyroid cancer patients
NCT ID NCT01896479
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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247 people
The number who actually took part.
- Started
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Feb 2015
- Expected to finish
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Jan 2035
An estimate. End dates often move.
- Lead sponsor
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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
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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: 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.
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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Study site
St Leonards, New South Wales, 2065, Australia
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Study site
Herston, Queensland, 4006, Australia
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Study site
Kurralta Park, South Australia, 5037, Australia
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Study site
Parkville, Victoria, 3050, Australia
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Study site
Québec, Quebec, JIH 5N4, Canada
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Study site
Toronto, M5G 2M9, Canada
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Study site
Osijek, 31000, Croatia
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Study site
Zagreb, 10000, Croatia
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Study site
Zagreb, 1000, Croatia
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Study site
Bordeaux, Gironde, 33076, France
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Study site
Angers, Maine-et-Loire, 49933, France
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Study site
Lyon, Rhône, 69373, France
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Study site
Villejuif, Val-de-Marne, 94805, France
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Study site
Dijon, 21079, France
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Study site
Paris, 75013, France
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Study site
Strasbourg, 67065, France
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Study site
Budapest, 1088, Hungary
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Study site
Debrecen, 4032, Hungary
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Study site
Jerusalem, 91120, Israel
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Study site
Petah Tikva, 49100, Israel
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Study site
Safed, 13100, Israel
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Study site
Catania, CT, 95124, Italy
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Study site
Roma, RM, 00161, Italy
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Study site
Siena, SI, 53100, Italy
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Study site
Pisa, Tuscany, 56124, Italy
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Study site
Milan, 20133, Italy
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Study site
Padua, 35138, Italy
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Study site
Torino, 10153, Italy
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Study site
Amsterdam, North Holland, 1066 CX, Netherlands
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Study site
Leiden, South Holland, 2333 ZA, Netherlands
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Study site
Groningen, 9713 GZ, Netherlands
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Study site
Poznan, Greater Poland Voivodeship, 60-355, Poland
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Study site
Gliwice, Silesian Voivodeship, 44-100, Poland
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Study site
Bucharest, 10825, Romania
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Study site
Bucharest, 11863, Romania
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Study site
Cluj-Napoca, 400058, Romania
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Study site
Timișoara, 300723, Romania
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Study site
Novosibirsk, 630068, Russia
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Study site
Obninsk, 249036, Russia
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Study site
Saint Petersburg, 197089, Russia
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Study site
Yaroslavl, 150040, Russia
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Study site
Goyang, Gyeonggido, 410769, South Korea
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Study site
Seoul, 110744, South Korea
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Study site
Seoul, 135-710, South Korea
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Study site
Barcelona, 08035, Spain
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Study site
Madrid, 28034, Spain
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Study site
Madrid, 28046, Spain
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Study site
Lund, Skane Ian, SE-22185, Sweden
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Study site
Uppsala, Uppsala Ian, 75185, Sweden
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Other studies related to the condition(s) this trial covers.
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