A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors
Data Collection
Treatment Study
Summary
Study start date: September 1, 2003
Actual 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Mary Crowley Medical Research Center
Dallas, United States