A Study of ARQ 171 in Patients With Advanced Solid Tumors

NCT ID: NCT00398840

Last Updated: 2017-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ARQ 171

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Arqule, Inc.

Locations

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Premiere Oncology

Santa Monica, California, United States

Site Status

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, United States

Site Status

Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ARQ 171-101

Identifier Type: -

Identifier Source: org_study_id

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