Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pemetrexed disodium · 2 trials · 4 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 |
|---|---|---|
| pemetrexed disodium | DRUG | - |
| bortezomib | 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: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Recurrent or persistent disease * Measurable disease * At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) ...
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