NCT00530192

Brief Summary

This is an open-label, multicenter pilot study in patients with advanced solid tumors. The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on. To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2006

Typical duration for early_phase_1

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

September 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 14, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 10, 2009

Status Verified

July 1, 2009

Enrollment Period

2.5 years

First QC Date

September 14, 2007

Last Update Submit

July 9, 2009

Conditions

Refractory Cancer

Keywords

Refractory CancerMolecular Profile

Outcome Measures

Primary Outcomes (1)

  • To compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.

    Every 8 weeks disease assessments are performed

Secondary Outcomes (2)

  • To determine the frequency with which molecular profiling of a patient's tumor by IHC/FISH and/or microarray analysis yields a target against which there is a commercially available, approved therapeutic regimen.

    Time of Profiling- Baseline

  • To determine the response rate (according to RECIST or disease-specific response criteria) and the percent of patients with non-progression at 4 months in patients with solid tumors whose therapy is selected by molecular profiling.

    4 months

Interventions

Treatment based on Molecular ProfilingOTHER

Treatment with commercially available treatments (per package insert instructions)

Eligibility Criteria

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

You may qualify if:

  • Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease.
  • Be defined as refractory to the last line of therapy
  • Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study

You may not qualify if:

  • Patients with symptomatic CNS metastasis
  • Any previous history of another malignancy within 5 years of study entry
  • Uncontrolled intercurrent illness
  • Known HIV, HBV, HCV infection
  • Pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Oncology Specialties

Huntsville, Alabama, 35805, United States

Location

TGen Clinical Research Services

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Tower Oncology

Beverly Hills, California, 90211, United States

Location

Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Central Indiana Cancer Center

Indianapolis, Indiana, 46227, United States

Location

Cancer Center of the Carolinas

Greenville, South Carolina, 29605, United States

Location

South Texas Oncology Hematology

San Antonio, Texas, 78229, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Daniel D Von Hoff, MD

    TGen Clinical Research Services at Scottsdale Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2007

First Posted

September 17, 2007

Study Start

September 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 10, 2009

Record last verified: 2009-07

Locations

US(9)