Cancer
Conditions
Keywords
Cancer, oral, erlotinib, tarceva, solid tumor, advanced tumor, phase 1, Tumor
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
Interventions
DRUGARQ 197
Treatment with ARQ 197 in combination with erlotinib
Sponsors
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | No time frame |
Secondary
| Measure | Time frame |
|---|---|
| To determine the pharmacokinetic profiles of ARQ 197 and erlotinib, when administered in combination to patients with advanced solid tumors | No time frame |
| To assess the preliminary anti-tumor activity of ARQ 197 when administered in combination with erlotinib to adult patients with advanced solid tumors | No time frame |
Countries
United States
Outcome results
None listed