Status and phase
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About
This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.
Enrollment
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Inclusion criteria
Has advanced, metastatic or unresectable GI tract tumors that are refractory or intolerant to existing available therapies and for whom the investigator recommends fluoropyrimidine monotherapy.
Has measurable disease in accordance with Respond Evaluation Criteria in Solid Tumors (RECIST) guidelines (Version 1.1).
Is aged ≥18 years
Has not received treatment with intravenous (IV) 5 FU or oral 5 FU analogs in the 4 weeks preceding enrollment
Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at study entry
Has adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:
Has a life expectancy of at least 12 weeks
Female patients of childbearing potential and male patients with partners capable of reproduction must agree to use an effective contraceptive method from the time of Screening through 60 days after the last dose of capecitabine
Females of childbearing potential must have a negative serum β human chorionic gonadotropin pregnancy test result
Willingly provides written, informed consent.
Has resolution or stabilization of acute toxicity from prior therapy to Grade <2 - except Grade 2 neuropathy
If patient has human immune deficiency virus (HIV) infection, it is controlled with undetectable viral load with antiretroviral treatment.
If patient has hepatitis C infection and received antiviral treatment, has a negative viral load at Screening
If patient has chronic hepatitis B infection and is receiving antiviral treatment, has a negative viral load at Screening.
Is willing and able to comply with all protocol required visits and assessments
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
23 participants in 1 patient group
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Central trial contact
Mary Nyberg
Data sourced from clinicaltrials.gov
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