ARQ 501 in Subjects With Cancer

NCT ID: NCT00075933

Last Updated: 2009-04-28

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-01-31

Brief Summary

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ARQ 501, an investigational anticancer drug, is intended to selectively kill cancer cells and spare normal cells by restoring and activating cellular checkpoints known to be defective in cancer using the Company's unique biology platform, Activated Checkpoint Therapy™ (ACT).

ARQ 501 has the potential for improved activity and reduced toxicity over other molecular approaches and traditional cancer chemotherapy.

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 501

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed solid tumor that is metastatic, unresectable or recurrent and for which standard curative or palliative measures do not exist or are no longer effective.
* ECOG performance status greater than or equal to 1
* Life expectancy greater than three months
* Acceptable pretreatment clinical laboratory results

Exclusion Criteria

* Subjects who have had chemotherapy or radiotherapy within 4 weeks
* Subjects receiving any other investigational agents
* Subjects with known untreated brain metastases
* Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD")
* Subjects with uncontrolled intercurrent illnesses
* Pregnant women
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

Principal Investigators

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Geoffrey I Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

C. Casey Cunningham, MD

Role: PRINCIPAL_INVESTIGATOR

Mary Crowley Medical Research Center

Locations

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Dana Farber/Partners CancerCare Inc

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 501-101

Identifier Type: -

Identifier Source: org_study_id

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