Overview

A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ArQule
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
Treatments:
Erlotinib Hydrochloride
Criteria
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)