Status:
COMPLETED
A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00612703
Start Date
February 1 2008
Last Update
July 23 2012
Active Locations (2)
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1
San Diego Pacific Oncology and Hematology Associates Inc.
Encinitas, California, United States, 92024
2
Premiere Oncology
Santa Monica, California, United States, 90404