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Medullary Thyroid CancerPhase 4EXAMINERNCT01896479

A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer

A Phase 4 study testing Cabozantinib (XL184) 140 mg and Cabozantinib (XL184) 60 mg in people with Medullary Thyroid Cancer, run by Exelixis at 49 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Medullary Thyroid Cancer
What is being tested?
Cabozantinib (XL184) 140 mg and Cabozantinib (XL184) 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
247 participants
Where
49 sitesin 14 countries
Study dates
25 Feb 2015to 31 Jan 2035
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has a histologically confirmed diagnosis of MTC.
  • 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.
  • 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.
  • 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.
  • 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.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
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  • The subject has adequate organ and marrow function
  • The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
  • 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.

Who cannot join

  • The subject has previously received cabozantinib.
  • 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.
  • Receipt of any systemic anti-tumor therapy within 28 days of randomization (42 days for nitrosoureas or/ mitomycin C).
  • Receipt of any other type of investigational agent within 28 days of randomization.
  • 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.
  • 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.
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  • Treatment at therapeutic doses with oral anticoagulants or platelet inhibitors (examples are warfarin and clopidogrel).
  • The subject has uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization.
  • The subject is unable to swallow multiple tablets or capsules.
  • The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation.
  • The subject is pregnant or breastfeeding.
  • 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.

Trial locations and contacts

49 sites in 14 countries.

49 sites in 14 countries

France7 sites

  • Study site

    Angers, Maine-et-Loire, 49933

  • Study site

    Bordeaux, Gironde, 33076

  • Study site

    Dijon, 21079

  • Study site

    Lyon, Rhône, 69373

  • Study site

    Paris, 75013

  • Study site

    Strasbourg, 67065

  • Study site

    Villejuif, Val-de-Marne, 94805

Other trials in France

Italy7 sites

  • Study site

    Catania, CT, 95124

  • Study site

    Milan, 20133

  • Study site

    Padua, 35138

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Roma, RM, 00161

  • Study site

    Siena, SI, 53100

  • Study site

    Torino, 10153

Other trials in Italy

Australia4 sites

  • Study site

    Herston, Queensland, 4006

  • Study site

    Kurralta Park, South Australia, 5037

  • Study site

    Parkville, Victoria, 3050

  • Study site

    St Leonards, New South Wales, 2065

Other trials in Australia

Romania4 sites

  • Study site

    Bucharest, 10825

  • Study site

    Bucharest, 11863

  • Study site

    Cluj-Napoca, 400058

  • Study site

    Timișoara, 300723

Other trials in Romania

Russia4 sites

  • Study site

    Novosibirsk, 630068

  • Study site

    Obninsk, 249036

  • Study site

    Saint Petersburg, 197089

  • Study site

    Yaroslavl, 150040

Other trials in Russia

Croatia3 sites

  • Study site

    Osijek, 31000

  • Study site

    Zagreb, 10000

  • Study site

    Zagreb, 1000

Other trials in Croatia

Israel3 sites

  • Study site

    Jerusalem, 91120

  • Study site

    Petah Tikva, 49100

  • Study site

    Safed, 13100

Other trials in Israel

Netherlands3 sites

  • Study site

    Amsterdam, North Holland, 1066 CX

  • Study site

    Groningen, 9713 GZ

  • Study site

    Leiden, South Holland, 2333 ZA

Other trials in Netherlands

South Korea3 sites

  • Study site

    Goyang, Gyeonggido, 410769

  • Study site

    Seoul, 110744

  • Study site

    Seoul, 135-710

Other trials in South Korea

Spain3 sites

  • Study site

    Barcelona, 08035

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28046

Other trials in Spain

Canada2 sites

  • Study site

    Québec, Quebec, JIH 5N4

  • Study site

    Toronto, M5G 2M9

Other trials in Canada

Hungary2 sites

  • Study site

    Budapest, 1088

  • Study site

    Debrecen, 4032

Other trials in Hungary

Poland2 sites

  • Study site

    Gliwice, Silesian Voivodeship, 44-100

  • Study site

    Poznan, Greater Poland Voivodeship, 60-355

Other trials in Poland

Sweden2 sites

  • Study site

    Lund, Skane Ian, SE-22185

  • Study site

    Uppsala, Uppsala Ian, 75185

Other trials in Sweden

About this study

Official title: A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

Being tested
Cabozantinib (XL184) 140 mg, Cabozantinib (XL184) 60 mg, Placebo tablet, Placebo capsule
Keywords
thyroid cancer, medullary thyroid cancer
Medical subject headings
Carcinoma, Medullary, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cabozantinib (XL184) 140 mgDrug

  • Cabozantinib (XL184) 60 mgDrug

  • Placebo tabletDrug

  • Placebo capsuleDrug

Study groups in NCT01896479
Study groupRoleWhat they receive
Cabozantinib (XL184) 60 mgExperimentalCabozantinib (XL184) 140 mg as capsules and placebo tablets administered orally once a day.
Receives: Drug: Cabozantinib (XL184) 60 mg; Drug: Placebo capsule
Cabozantinib (XL184) 140 mgExperimentalCabozantinib (XL184) 140 mg as tablets and placebo capsules administered orally once a day.
Receives: Drug: Cabozantinib (XL184) 140 mg; Drug: Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    PFS per BIRC per RECIST 1.1 was measured from randomization until the date of first documented disease progression or date of death from any cause, whichever came first, and was assessed for up to 31 months. The prespecified primary analysis was triggered by the required number of at least 150 events occurring in the ITT population, The data cutoff date for this event-driven analysis in the ITT population was when a total of 155 events were reported. Median PFS was calculated using the Kaplan-Meier estimates.

    Measured: Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months

Secondary outcomes (1)

  1. Objective Response Rate (ORR) Per BIRC Per RECIST 1.1

    ORR per BIRC per RECIST 1.1 is the percentage of ITT participants who experienced a best overall response of complete response (CR) or partial response (PR), confirmed ≥ 28 days later, CR defined as disappearance of all non-target lesions. All lymph nodes must have been non-pathological in size (<10 mm short axis). PR defined as unequivocal progression of non-target lesions. Unequivocal progression was to trump target lesion status. It must have been representative of overall disease status change, not a single lesion increase.

    Measured: Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2013 (estimated)
  2. Study start25 Feb 2015
  3. Primary completion15 Jul 2020
  4. Study completion31 Jan 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01896479
Sponsor's protocol ID
XL184-401
Other IDs
2024-516480-90-00
Acronym
EXAMINER
Status last verified
Sep 2026
First submitted
8 Jul 2013
Last updated
20 Oct 2026
Data monitoring committee
Yes

Publications

  • Capdevila J, Klochikhin A, Leboulleux S, Isaev P, Badiu C, Robinson B, Hughes BGM, Keam B, Parnis F, Elisei R, Gajate P, Gan HK, Kapiteijn E, Locati L, Mangeshkar M, Faoro L, Krajewska J, Jarzab B. A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer. Thyroid. 2022 May;32(5):515-524. doi: 10.1089/thy.2022.0027.

    PubMed 35403447

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cabozantinib (XL184) 140 mg and Cabozantinib (XL184) 60 mg in people with Medullary Thyroid Cancer, run by Exelixis at 49 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in France, Italy, Australia, Romania, Russia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Per Blinded Independent Radiology Committee (BIRC) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (time frame: Median time of follow-up (from the date of randomization of the first participant through primary data cut off [15 July 2020]) was 30.2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01896479, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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