Refractory Cancer
Conditions
Keywords
Refractory Cancer, Molecular Profile
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.
Interventions
OTHERTreatment based on Molecular Profiling
Treatment with commercially available treatments (per package insert instructions)
Sponsors
Scottsdale Healthcare
Translational Genomics Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed