Completed

ARQ 501 in Subjects With Cancer

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What is being tested

ARQ 501

Drug
Who is being recruted

Cancer

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2003

See protocol details

Summary

Principal SponsorArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Last updated: April 28, 2009
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors 
Principal SponsorArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Last updated: April 28, 2009
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
80 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cancer
Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Dana Farber/Partners CancerCare IncBoston, United StatesSee the location
Suspended
Mary Crowley Medical Research CenterDallas, United States
Completed2 Study Centers