ARQ 501 in Subjects With Cancer

Cancer Clinical Trial

Official title:

A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00075933
• Other study ID #: ARQ 501-101
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2004
• Last updated: April 27, 2009
• Start date: September 2003
• Est. completion date: January 2007

Study information

• Verified date: April 2009
• Source: ArQule
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• ARQ 501

Locations

Country	Name	City	State
United States	Dana Farber/Partners CancerCare Inc	Boston	Massachusetts
United States	Mary Crowley Medical Research Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ArQule

Country where clinical trial is conducted

United States,