Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
gene expression analysis · 1 trial · 2 indications
Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion or lasting \>7 days; febrile neutropenia; grade 3 neutropenia associated with infection; any other grade \>/=3 non-hematologic toxicity considered by the investigator to be related to study drug.
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 (Phase I).
Grade 3/4 toxicity occurring in a patient within 1 cycle.
To determine the response rate of bortezomib in combination with pemetrexed in patients with advanced NSCLC. Response rate was assessed by CT scan. CT scans was performed at baseline and every two cycles (prior to 3rd and 5th cycle). The evaluation of response was based on standard RECIST criteria.
| Name | Type | Description |
|---|---|---|
| bortezomib | DRUG | - |
| pemetrexed disodium | DRUG | - |
| gene expression analysis | GENETIC | - |
| mutation analysis | GENETIC | - |
| protein expression analysis | GENETIC | - |
| reverse transcriptase-polymerase chain reaction | GENETIC | - |
| flow cytometry | OTHER | - |
| immunoenzyme technique | OTHER | - |
| immunohistochemistry staining method | OTHER | - |
DISEASE CHARACTERISTICS: * Cytologically or histologically confirmed diagnosis of 1 of the following: * Advanced solid tumor that progressed after standard therapy or for which no effective curative therapy exists (phase I) * Stage IIIB (pleural effusion) or IV non-small cell lung cancer (NSCL...
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Gene expression analysis is an investigational gene therapy approach being studied in lung cancer. It is being evaluated in a Phase 1 clinical trial for patients with advanced non-small cell lung cancer or other solid tumors. The therapy is still in clinical development and is not approved.
Gene expression analysis is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting clinical research on this investigational gene therapy for oncology applications.
Gene expression analysis is in Phase 1 clinical development. It is an investigational gene therapy being studied for lung cancer and other solid tumors. The therapy is not approved and remains in early-stage clinical trials.
Gene expression analysis is associated with clinical trial NCT00389805, a Phase 1 study titled 'Bortezomib and Pemetrexed Disodium in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors.' This completed trial enrolled 27 participants in the United States.
Gene expression analysis is a broad term referring to a laboratory technique, not a specific drug. In the context of this clinical trial, it is used as a biomarker selection method to guide treatment. The trial itself evaluates the combination of bortezomib and pemetrexed disodium.