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

Phase 1
18 Years
Not Enrolling

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Trial Information

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

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

No time frame

Safety Issue:


Principal Investigator

Lee Rosen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Premiere Oncology of Santa Monica


United States: Food and Drug Administration

Study ID:

ARQ 197-111



Start Date:

February 2008

Completion Date:

Related Keywords:

  • Cancer
  • Cancer, oral, erlotinib, tarceva, solid tumor, advanced tumor, phase 1
  • Tumor



Premiere Oncology Santa Monica, California  90404
San Diego Pacific Oncology and Hematology Associates Inc. Encinitas, California  92024