NCT00398840TerminatedPhase 1
A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)6 sites in 1 country14 target enrollmentStarted: November 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 14
- Locations
- 6
- Primary Endpoint
- To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
Study Overview
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 therapy or for whom no standard systemic therapy exists, will be enrolled.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
Secondary Outcomes
- To determine the pharmacokinetic profile of ARQ 171
- To assess the preliminary anti-tumor activity of ARQ 171
Investigators
Study Sites (6)
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