Molecular Profiling Protocol (SCRI-CA-001)

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers

Conditions
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Refractory Cancer

Intervention / Treatment
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* Other: Treatment based on Molecular Profiling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Treatment based on Molecular Profiling|Treatment with commercially available treatments (per package insert instructions)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Cancer, Molecular Profile