Expanded Access to Cabozantinib for Medullary Thyroid Cancer
Sponsor: Exelixis
Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT01683110
This program provides access to the drug cabozantinib for patients with medullary thyroid cancer (MTC) while awaiting its official approval and availability.
Patient Parameters
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Program Overview
The aim of this program is to offer the drug cabozantinib to patients with medullary thyroid cancer (MTC) who meet certain criteria, while the drug is pending approval and commercial availability. This allows eligible patients to access the treatment before it becomes widely available.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with medullary thyroid cancer (MTC) that cannot be surgically removed, has spread locally, or has metastasized.
- The cancer is progressing, as determined by the doctor.
- Previously treated with standard therapies for MTC, or other available treatments are not suitable.
- General health status allows participation, with a performance score of 0 to 2.
- Adequate organ and bone marrow function.
- Able to understand and follow the study requirements and has signed a consent form.
- Sexually active participants must agree to use barrier methods of contraception, like condoms, during the study and for 3 months after the last dose, even if using other birth control methods.
Exclusion Criteria
- Received chemotherapy or biological agents within 4 weeks, or certain other treatments within 6 weeks before starting cabozantinib.
- Previously participated in a cabozantinib trial, even if not treated with the drug.
- Received radiation therapy to certain areas within specific timeframes before starting cabozantinib.
- Received radionuclide treatment within 6 weeks before starting cabozantinib.
- Treated with kinase inhibitors or hormonal therapies within 14 days or longer, depending on the drug's half-life, before starting cabozantinib.
- Participated in another investigational study within 28 days before starting cabozantinib.
- Not fully recovered from side effects of previous treatments, except for hair loss or other minor effects.
- Have active brain metastases or epidural disease, with some exceptions.
- Require ongoing treatment with certain strong medications that affect liver enzymes.
- Need to take blood thinners or antiplatelet drugs, except for low-dose aspirin or similar medications.
- Have had significant gastrointestinal bleeding or coughing up blood recently.
- Have tumors affecting major blood vessels or the gastrointestinal tract.
- Have uncontrolled or serious recent illnesses, including certain heart or digestive disorders.
- Cannot swallow capsules.
- Are pregnant or breastfeeding.
- Cannot or will not follow the study protocol or cooperate with the study team.
- Have had another cancer diagnosis requiring treatment within the last two years, unless treated with curative intent and not on other cancer therapies.
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