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Medullary Thyroid CancerNCT01683110

Expanded Access of Cabozantinib in Medullary Thyroid Cancer

A study testing cabozantinib in people with Medullary Thyroid Cancer, run by Exelixis at 5 sites in United States.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to provide access to cabozantinib for eligible subjects with medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by the FDA and commercial availability of cabozantinib. 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
How many people
Not given
Where
5 sitesUnited States
Study dates
Start not givento not given
Phase
Expanded access
Are there results?
None posted in the registry

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
  • Adult, Older adult

Who may be able to join

  • The subject has histologically confirmed diagnosis of MTC that is unresectable, locally advanced, or metastatic
  • The subject has documented progressive disease (PD) as determined by the investigator
  • The subject has been previously treated with available standard therapy for unresectable, locally advanced, or metastatic MTC; or other currently available therapy is considered inappropriate for the subject as determined by the investigator
  • The subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • 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 subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 3 months after the last dose of cabozantinib received as part of this study, even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control.

Who cannot join

  • The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, antibodies) within 4 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of cabozantinib
  • The subject has previously been enrolled in a clinical trial evaluating cabozantinib including placebo-controlled trials in which the subject may not have been treated with cabozantinib
  • The subject has received radiation therapy:
  • to the thoracic cavity, abdomen, or pelvis within 12 weeks before the first dose of study treatment , or has ongoing complications or is without complete recovery and healing from prior radiation therapy
  • to bone or brain metastasis within 14 days before the first dose of cabozantinib
  • to any other site(s) within 28 days before the first dose of cabozantinib
Show all 25Show fewer
  • The subject has received radionuclide treatment within 6 weeks before the first dose of cabozantinib
  • The subject has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 14 days or five half-lifes of the compound or active metabolites, whichever is longer, before the first dose of cabozantinib
  • The subject has received any other type of investigational agent within 28 days before the first dose of cabozantinib
  • The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other clinically non-significant side effects
  • The subject has active brain metastases or epidural disease (certain exceptions apply)
  • The subject requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort)
  • The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel). Low dose aspirin (≤ 81 mg/day), low-dose warfarin (≤ 1 mg/day), and prophylactic low molecular weight heparin are permitted
  • The subject has experienced any of the following:
  • clinically-significant GI bleeding within 6 months before the first dose of cabozantinib
  • hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood within 3 months before the first dose of cabozantinib
  • any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of cabozantinib
  • The subject has radiographic evidence of cavitating pulmonary lesion(s)
  • The subject has radiographic evidence of tumor in contact with, invading or encasing any major blood vessel
  • The subject has evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
  • The subject has uncontrolled, significant intercurrent or recent illness (which may include certain cardiac disorders, certain gastrointestinal disorders, and major surgeries)
  • The subject is unable to swallow capsules
  • The subject is pregnant or breastfeeding
  • The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
  • The subject has had another diagnosis of malignancy, requiring systemic treatment, within two years before the first dose of cabozantinib, unless that malignancy has been treated with curative intent and the subject is taking no other anti-cancer therapy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Portland, Oregon, 97239

  • Study site

    Stanford, California, 94305

Other trials in United States

About this study

Official title: An Open-Label, Expanded Access Study of Cabozantinib (XL184) in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

The objective of this study is to provide access to cabozantinib for eligible subjects with medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application (NDA) by the FDA and commercial availability of cabozantinib.

Being tested
cabozantinib
Medical subject headings
Carcinoma, Medullary

What participants receive

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

Timeline

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

  1. First posted11 Sep 2012 (estimated)

Resources

More details

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

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT01683110
Sponsor's protocol ID
XL184-209
Status last verified
Jan 2013
First submitted
7 Sep 2012
Last updated
16 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing cabozantinib in people with Medullary Thyroid Cancer, run by Exelixis at 5 sites in United States.

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 7 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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.

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01683110.

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 16 Jan 2013.

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