NCT00358930

Brief Summary

This is a Phase 2, multi-center, open label study of ARQ 501 in patients with locally advanced, recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

9 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

July 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

1.1 years

First QC Date

July 28, 2006

Last Update Submit

April 27, 2009

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Keywords

squamous cell carcinoma of the head and neck

Outcome Measures

Primary Outcomes (1)

  • Assess the overall response rate (ORR) of patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with ARQ 501.

Secondary Outcomes (1)

  • Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.

Interventions

ARQ 501DRUG

Eligibility Criteria

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

You may qualify if:

  • Able to provide signed and dated informed consent document prior to study-specific screening procedures.
  • Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN.
  • Measurable disease per RECIST.
  • ≥ 18 years old.
  • Karnofsky performance status (KPS) ≥ 70%.
  • Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501.
  • Hemoglobin (Hgb) ≥ 10 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (≥ 1,500/mm³).
  • Platelet count ≥ 100 x 10\^9/L ( ≥ 100,000/mm³).
  • Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 3.0 x ULN with metastatic liver disease.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN or less than or equal to 5.0 x ULN with metastatic liver disease.
  • Creatinine less than or equal to 1.5 x ULN.

You may not qualify if:

  • Primary tumor of nasopharyngeal origin.
  • Eligible for curative surgery or radiotherapy.
  • Received three or more systemic anticancer regimens.
  • Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
  • Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion.
  • Surgery within two weeks of first infusion.
  • Have symptomatic or untreated central nervous system (CNS) involvement.
  • Are pregnant or lactating.
  • Previous exposure to ARQ 501.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of South Alabama

Mobile, Alabama, 36693, United States

Location

LA County Hospital

Los Angeles, California, 90033, United States

Location

Norris Comprehensive Cancer Center

Los Angeles, California, 90089-0178, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Dana-Farber

Boston, Massachusetts, 02218, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

New York Oncology Hematology

Albany, New York, 12208, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous CellSquamous Cell Carcinoma of Head and Neck

Interventions

beta-lapachone

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

July 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

US(9)