Know Cancer

forgot password

A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Metastatic Solid Tumors

Phase 1
18 Years
Not Enrolling
Cancer, Tumor

Thank you

Trial Information

A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Metastatic Solid Tumors

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 given
orally. This is an open label, dose escalation study of ARQ 197 administered orally at a
starting dose of 10 mg bid (20 mg/day).

Inclusion Criteria:

- Signed written informed consent must be obtained and documented according to ICH GCP,
the local regulatory requirements, and permission to use private health information
in accordance with HIPPA prior to study-specific screening procedures

- A histologically or cytologically confirmed RCC or other c-Met expression tumors that
is metastatic

- Patient must have available archival tumor tissue or accessible tumor that is safely
amenable to tumor biopsy

- ≥ 18 years of age

- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors

- Karnofsky performance status ≥ 70%

- Male or female patients of child-producing potential must agree to use contraception
or avoidance of pregnancy measures during the study and for 30 days after the last
ARQ 197 dose

- Females of childbearing potential must have a negative serum pregnancy test

- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of
normal (ULN) or ≤ 5.0 × ULN with metastatic liver disease.

- Hemoglobin (Hgb) ≥ 10 g/dl

- Total bilirubin ≤ 1.5 × ULN

- Creatinine ≤ 1.5 x ULN

- Absolute neutrophil count ≥ 1.5 x 10^9/L

- Platelets ≥ 100 x 10^9/L

Exclusion Criteria:

- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
within four weeks of first dose

- Surgery within 4 weeks prior to first dose

- Known brain metastases

- Pregnant or breastfeeding

- Significant gastrointestinal disorder(s), in the opinion of the Principal
Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric

- Unable or unwilling to swallow ARQ 197 capsules twice daily

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, clinically significant non-healing or healing wounds, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant
pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled
infection or psychiatric illness/social situations that would limit compliance with
study requirements

- Bradycardia at baseline or known history of arrhythmia

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety, tolerability

Outcome Time Frame:

All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met

Safety Issue:



United States: Food and Drug Administration

Study ID:

ARQ 197-101



Start Date:

January 2006

Completion Date:

Related Keywords:

  • Cancer
  • Tumor
  • Cancer
  • solid tumor
  • metastatic
  • primary tumor



Mary Crowley Medical Research Center Dallas, Texas  75246
Premiere Oncology Santa Monica, California  90404
The Cleveland Clinic Cleveland, Ohio  44195