NCT00075933

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Sep 2003

Typical duration for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

3.3 years

First QC Date

January 12, 2004

Last Update Submit

April 27, 2009

Conditions

Cancer

Interventions

ARQ 501DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana Farber/Partners CancerCare Inc

Boston, Massachusetts, 02115, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

beta-lapachone

Study Officials

  • Geoffrey I Shapiro, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

  • C. Casey Cunningham, MD

    Mary Crowley Medical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2004

First Posted

January 13, 2004

Study Start

September 1, 2003

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

US(2)