Status:
TERMINATED
A Study of ARQ 171 in Patients With Advanced Solid Tumors
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00398840
Start Date
November 1 2006
End Date
September 1 2008
Last Update
March 6 2017
Active Locations (3)
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1
Premiere Oncology
Santa Monica, California, United States, 85260
2
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, United States, 02115
3
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201