Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
anti-IGF-1R recombinant monoclonal antibody MK-0646 · 1 trial · 1 indication
Evaluate safety, tolerability in combination with standard chemotherapy.
Look at toxicity and tolerability of MK0646 in combination with standard therapy.
Look for evidence of response
Determine objective response rate including complete response rate, progression free survival and overall survival.
Blood samples will be collected and analyzed for occurrence of human-anti-humanized antibody response to MK0646 as well as IGF-1R analysis.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | MK-0646, a monoclonial antibody in combination with etoposide and cisplatin. |
| Name | Type | Description |
|---|---|---|
| anti-IGF-1R recombinant monoclonal antibody MK-0646 | BIOLOGICAL | MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days |
| cisplatin | DRUG | MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days |
| etoposide | DRUG | MK-0646 should be given 1st followed within 30-60 minutes by cisplatin and then etoposide for cycles which include both MK-0646 and chemotherapy. Cycles are 21 days |
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer (SCLC) * Extensive stage disease that is incurable but amenable to treatment with platinum-based chemotherapy * Small cell and variant histologies allowed * No mixed tumors (i.e., small and large cell...
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