Expanded Access of Cabozantinib in Medullary Thyroid Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01683110
• Date of registration: 07/09/2012
• Prospective Registration: No
• Primary sponsor: Exelixis
• Public title: Expanded Access of Cabozantinib in Medullary Thyroid Cancer
• Scientific title: An Open-Label, Expanded Access Study of Cabozantinib (XL184) in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer
• Date of first enrolment: March 2009
• Recruitment status: Approved for marketing
• URL: http://clinicaltrials.gov/show/NCT01683110
• Study type: Expanded Access
• Study design: N/A
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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:

1. 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

2. to bone or brain metastasis within 14 days before the first dose of cabozantinib

3. to any other site(s) within 28 days before the first dose of cabozantinib

- 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:

1. clinically-significant GI bleeding within 6 months before the first dose of
cabozantinib

2. hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood within 3 months before the
first dose of cabozantinib

3. 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Medullary Thyroid Cancer

Intervention(s)

Drug: cabozantinib

Secondary ID(s)

XL184-209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors