NCT00622063

Brief Summary

To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1 cancer

Geographic Reach
1 country

1 active site

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

December 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

February 12, 2008

Last Update Submit

February 22, 2013

Conditions

Cancer

Keywords

cancer, solid tumor

Outcome Measures

Primary Outcomes (1)

  • To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501

    No time frame

Secondary Outcomes (1)

  • To collect additional safety and tolerability information for ARQ 501 treatment

    No time frame

Interventions

ARQ 501DRUG

Treatment with ARQ 501 or ARQ 501 as combination therapy at the dose and regimen previously received

Eligibility Criteria

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

You may qualify if:

  • Signed written informed consent
  • Has previous participated in a clinical trial with ARQ 501 and is eligible for continued treatment

You may not qualify if:

  • Have not received previous treatment with ARQ 501 under a treatment protocol
  • Uncontrolled intercurrent illness, uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

beta-lapachone

Study Officials

  • Neil Nathan Senzer, MD

    Mary Crowley Medical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2008

First Posted

February 22, 2008

Study Start

December 1, 2006

Primary Completion

September 1, 2008

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)