ARQ 197 in Subjects With Metastatic Solid Tumors

NCT00302172 | Completed Phase 1

• 1 other identifier: ARQ 197-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

Conditions

Cancer; Tumor

Keywords

Cancer; solid tumor; metastatic; primary tumor

Outcome Measures

Primary Outcomes (1)

• safety, tolerability

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

Secondary Outcomes (3)

• 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.

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

• To assess the preliminary anti-tumor activity of ARQ 197.

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

Study Arms (1)

ARQ 197

EXPERIMENTAL

Drug: ARQ 197

Interventions

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.

ARQ 197

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA): lead

Study Sites (3)

Premiere Oncology

Santa Monica, California, 90404, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

ARQ 197

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: January 1, 2006
• Last Updated: August 26, 2009

Record last verified: 2009-08

Locations

US (3)