A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
A histologically or cytologically confirmed solid tumor that is advanced, metastatic, and/or inoperable following prior standard chemotherapy, and/or for which, in the opinion of the investigator, there is no alternative therapy, or for which monotherapy with erlotinib is appropriate
≥ 18 years of age
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose (patients currently on erlotinib monotherapy may be enrolled into the study without a washout)
Major surgery within 4 weeks prior to first dose
Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms
Pregnant or breastfeeding
Significant gastrointestinal disorder that, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection)