Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pemetrexed - Before Protocol Amendment
Pemetrexed- Before Protocol Amendment · 1 trial · 1 indication
dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction \[PCR\] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
| Arm | Type | Description |
|---|---|---|
| Pemetrexed - Before Protocol Amendment | EXPERIMENTAL | - |
| Pemetrexed - After Protocol Amendment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Pemetrexed - Before Protocol Amendment | DRUG | 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue |
| Pemetrexed - After Protocol Amendment | DRUG | 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue. |
Inclusion Criteria * Histologically or cytologically proven IIIB and IV NSCLC. * No symptomatic uncontrolled brain metastasis * Not suitable for platinum containing regimens if chemo-naive * Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale. * Creatin...
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