A Study of ARQ 171 in Patients With Advanced Solid Tumors

Phase 1

Terminated

• Conditions: Cancer

• Registration Number: NCT00398840
• Lead Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-14
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic profile of ARQ 171
To assess the preliminary anti-tumor activity of ARQ 171

Trial Locations

Locations (3)

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