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The purpose of this program is to provide access to tucatinib in the United States before FDA approval.
Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib. All treatments will be given on a 21 day cycle.
To learn more about this program, contact Seattle Genetics' Medical Information (medinfo@seagen.com).
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Inclusion criteria
Exclusion criteria
Eligible for a tucatinib clinical trial
Disease recurrence within 3 months of last capecitabine for metastatic disease
History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the protocol drugs
Have received treatment with any systemic anti-cancer therapy (excluding hormonal therapy), non-CNS radiation, or experimental agent ≤ 3 weeks of first dose of protocol treatment or are currently participating in an interventional clinical trial. Have received hormonal therapies <1 week of the first dose of protocol treatment.
Have any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:
Have clinically significant cardiopulmonary disease
Have known myocardial infarction or unstable angina within 6 months prior to first dose of protocol treatment
Are known carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease with uncontrolled disease
Are known to be positive for HIV with uncontrolled disease
Are pregnant, breastfeeding, or planning a pregnancy
Require therapy with warfarin or other coumarin derivatives (non-coumarin anticoagulants are allowed)
Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications
Have used strong CYP2C8 inhibitor within 5 half-lives of the inhibitor, or have used a CYP2C8 or CYP3A4 inducer within 5 day prior to start of tucatinib treatment.
Have known dihydropyrimidine dehydrogenase deficiency
Have evidence within 2 years of the start of protocol treatment of another malignancy that required systemic treatment.
CNS Exclusion - patients must not have any of the following:
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Data sourced from clinicaltrials.gov
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