A Phase 1 Dose Escalation Study of ARQ 197 Administered in Combination With Erlotinib in Adult Patients With Advanced Solid Tumors

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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)