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Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters.
Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD.
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Inclusion criteria
Weight: male weight ≥ 45 kg; female weight ≥ 40 kg, body mass index (BMI) between 18~24 kg/m^2, including the boundary values;
The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival;
Not treated with standard therapeutical regime currently, or has progressed or relapsed after standard treatment;
Time from last cytotoxic chemotherapy (including investigational cytotoxic agents) or biologic agents (immune modulators, cytokines) ≥ 4 weeks, or nitrosoureas or mitomycin C ≥ 6 weeks. If having received an antibody anti-tumor biological product, at least 8-week washout period is required;
At least 4 weeks after surgery, and the wound must be healed completely;
If subject has chemotherapy-induced toxicity, the adverse events must be recovered to ≤ grade 1 (NCI-CTC version 4.0) except for alopecia;
ECOG performance status of 0-2;
Expected survival time is more than three months;
The subject has organ and marrow function as follows:
The subject is capable of understanding and complying with the protocol and has signed the informed consent document;
Exclusion criteria
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18 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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