A Study of ARQ 171 in Patients With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Cancer

In brief

This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion (IVI) into a peripheral vein weekly. Patients with advanced solid tumors, who are refractory to available therapy or for whom no standard systemic therapy exists, will be enrolled.

Key facts

Study ID

NCT00398840

Run by

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

People needed

14

Starts

2006-11-01

Expected to finish

2008-09-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent must be obtained and documented prior to study-specific screening procedures.
• A histologically or cytologically confirmed advanced solid tumor
• ≥ 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 participation.
• Females of childbearing potential must have a negative serum pregnancy test.
• Laboratory results must meet study criteria.

You may not qualify if…

• Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first infusion
• Surgery within 4 weeks prior to first infusion
• Known untreated brain metastases
• Pregnant or breastfeeding
• Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
• Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin

Where it is running

• Premiere Oncology — Santa Monica, California, United States
• Dana Farber/Harvard Cancer Center — Boston, Massachusetts, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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