ARQ 197 in Subjects With Metastatic Solid Tumors | NCT00302172

NCT00302172

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
ARQ 197	Experimental		Drug: ARQ 197

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARQ 197	Drug	Patients in this trial will receive ARQ 197 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 20 mg/day (first cohort) and escalate until the RP2D or MTD is determined. Patients enrolled under a previous amendment will continue to receive ARQ 197 twice daily for 14 days followed by 7 days without therapy. Any patient enrolled under Amendment 3 will take ARQ 197 twice daily for 21 days where cycles will be repeated every three-weeks (21 days). Patients enrolled under Amendment 4 will receive dose of 360 mg bid (720 mg daily) continuously for 21 days, and cycle will be repeated every three weeks. All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted.

Outcomes Module

Measure	Description	Time Frame
safety, tolerability		All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met

Secondary Outcomes

Measure	Description	Time Frame
To determine the pharmacokinetic profile of ARQ 197.		All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
To determine the pharmacodynamics (i.e., identify biomarkers) of ARQ 197.

Eligibility Module

Eligibility Criteria

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 resection)
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

Facility	Status	City	State	ZIP	Country	Contacts
Premiere Oncology		Santa Monica	California	90404	United States
The Cleveland Clinic

ID	Term
D009369	Neoplasms
D009362	Neoplasm Metastasis

ID	Term
D009385	Neoplastic Processes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms