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| ID | Type | Description | Link |
|---|---|---|---|
| SCRI-CA-001 |
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| Name | Class |
|---|---|
| Translational Genomics Research Institute | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment based on Molecular Profiling | Other | Treatment with commercially available treatments (per package insert instructions) |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel D Von Hoff, MD | TGen Clinical Research Services at Scottsdale Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Specialties | Huntsville | Alabama | 35805 | United States | ||
| TGen Clinical Research Services |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 4 months |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States |
| Tower Oncology | Beverly Hills | California | 90211 | United States |
| Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Central Indiana Cancer Center | Indianapolis | Indiana | 46227 | United States |
| Cancer Center of the Carolinas | Greenville | South Carolina | 29605 | United States |
| South Texas Oncology Hematology | San Antonio | Texas | 78229 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |