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.

Condition	Treatment or Intervention	Phase
Cancer	Drug: ARQ 501	Phase I

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Massachusetts
      Dana Farber/Partners CancerCare Inc, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Adam Craig, MBBS, PhD, MRCP,  Study Chair,  ArQule, Inc.   

Study ID Numbers:  ARQ 501-101
Record last reviewed:  July 2004
Record first received:  January 12, 2004
ClinicalTrials.gov Identifier:  NCT00075933
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29