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

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: ARQ 197

Study type

Interventional

Funder types

Industry

Identifiers

NCT00612703

ARQ 197-111

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)