Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00389805 | Bortezomib and Pemetrexed Disodium in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors | PHASE1 | COMPLETED | 27 | — | — | Mar 1, 2005 | Jun 1, 2007 | Oct 31, 2018 | 1 | United States |
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...