- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00398840
A Study of ARQ 171 in Patients With Advanced Solid Tumors
March 2, 2017 updated by: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors
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 Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Monica, California, United States, 85260
- Premiere Oncology
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana Farber/Harvard Cancer Center
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Texas
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Dallas, Texas, United States, 75201
- Mary Crowley Medical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171
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Secondary Outcome Measures
Outcome Measure |
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To determine the pharmacokinetic profile of ARQ 171
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To assess the preliminary anti-tumor activity of ARQ 171
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2006
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
November 9, 2006
First Submitted That Met QC Criteria
November 9, 2006
First Posted (Estimate)
November 14, 2006
Study Record Updates
Last Update Posted (Actual)
March 6, 2017
Last Update Submitted That Met QC Criteria
March 2, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ARQ 171-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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